Trial Outcomes & Findings for Intraperitoneal vs Intravenous Chemotherapy Following Neoadjuvant Chemotherapy in Ovarian Cancer (NCT NCT00993655)
NCT ID: NCT00993655
Last Updated: 2023-08-28
Results Overview
It is defined as proportion of patients who had progressed at or before 9 months after randomization, i.e., the time from the randomization to the date when the first observation of disease progression (earliest of the date when the first CA 125 meets progression definition and the date of first objective relapse or progression, defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, recorded) has been documented or when death due to any cause has been observed was less than or equal to 9 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
275 participants
Primary outcome timeframe
9 months
Results posted on
2023-08-28
Participant Flow
Participant milestones
| Measure |
Arm 1
ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles
carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
|
Arm 2
ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)
cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy
|
Arm 3
ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
101
|
72
|
102
|
|
Overall Study
COMPLETED
|
101
|
72
|
102
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraperitoneal vs Intravenous Chemotherapy Following Neoadjuvant Chemotherapy in Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Arm 1
n=101 Participants
ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles
carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
|
Arm 2
n=72 Participants
ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)
cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy
|
Arm 3
n=102 Participants
ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy
|
Total
n=275 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62 years
n=99 Participants
|
61 years
n=107 Participants
|
62 years
n=206 Participants
|
62 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
275 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
92 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
254 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
65 participants
n=99 Participants
|
42 participants
n=107 Participants
|
66 participants
n=206 Participants
|
173 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
3 participants
n=206 Participants
|
10 participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
27 participants
n=99 Participants
|
20 participants
n=107 Participants
|
27 participants
n=206 Participants
|
74 participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
6 participants
n=206 Participants
|
18 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: All randomized patients
It is defined as proportion of patients who had progressed at or before 9 months after randomization, i.e., the time from the randomization to the date when the first observation of disease progression (earliest of the date when the first CA 125 meets progression definition and the date of first objective relapse or progression, defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, recorded) has been documented or when death due to any cause has been observed was less than or equal to 9 months.
Outcome measures
| Measure |
Arm 1
n=101 Participants
ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles
carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
|
Arm 2
n=72 Participants
ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)
cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy
|
Arm 3
n=102 Participants
ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy
|
|---|---|---|---|
|
9-month Progression Rate Post-randomization
|
0.386 Porportion of participants
|
0.347 Porportion of participants
|
0.245 Porportion of participants
|
SECONDARY outcome
Timeframe: During the study with median follow-up of 33 monthsPopulation: All patients randomized to the study
Time from the day of randomization until the time when first observation of disease progression (earliest of the dates of first CA125 which meets progression definition and first objective relapse or progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, has been documented or when death due to any cause has been observed.
Outcome measures
| Measure |
Arm 1
n=101 Participants
ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles
carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
|
Arm 2
n=72 Participants
ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)
cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy
|
Arm 3
n=102 Participants
ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy
|
|---|---|---|---|
|
Progression Free Survival
|
11.3 months
Interval 8.8 to 14.7
|
12.7 months
Interval 9.7 to 18.0
|
12.5 months
Interval 10.8 to 15.0
|
SECONDARY outcome
Timeframe: During the study with median follow-up of 33 monthsTime from the day of randomization to death from any cause.
Outcome measures
| Measure |
Arm 1
n=101 Participants
ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles
carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
|
Arm 2
n=72 Participants
ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)
cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy
|
Arm 3
n=102 Participants
ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy
|
|---|---|---|---|
|
Overall Survival
|
38.1 months
Interval 32.9 to 47.7
|
40.6 months
Interval 38.7 to 68.1
|
59.3 months
Interval 34.2 to 68.3
|
Adverse Events
Arm 1
Serious events: 7 serious events
Other events: 94 other events
Deaths: 34 deaths
Arm 2
Serious events: 8 serious events
Other events: 64 other events
Deaths: 24 deaths
Arm 3
Serious events: 6 serious events
Other events: 92 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Arm 1
n=95 participants at risk
ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles
carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
|
Arm 2
n=67 participants at risk
ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)
cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy
|
Arm 3
n=92 participants at risk
ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy
|
|---|---|---|---|
|
Infections and infestations
Abdominal infection
|
0.00%
0/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.5%
1/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.5%
1/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.5%
1/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.5%
1/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.5%
1/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.5%
1/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.1%
1/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.5%
1/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.5%
1/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.1%
1/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
General disorders
Infusion related reaction
|
0.00%
0/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.1%
1/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Injury, poisoning and procedural complications
Intraoperative gastrointestinal injury
|
0.00%
0/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.1%
1/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.1%
1/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Blood and lymphatic system disorders
Anemia
|
1.1%
1/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.3%
5/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.1%
1/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.5%
1/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.1%
1/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Investigations
Neutrophil count decreased
|
1.1%
1/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
1.1%
1/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.1%
1/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.1%
1/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.1%
1/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.5%
1/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
General disorders
Infusion site extravasation
|
0.00%
0/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
3.0%
2/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
Other adverse events
| Measure |
Arm 1
n=95 participants at risk
ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles
carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
|
Arm 2
n=67 participants at risk
ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)
cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy
|
Arm 3
n=92 participants at risk
ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles
paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.3%
5/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.5%
1/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.1%
1/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Cardiac disorders
Palpitations
|
6.3%
6/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.1%
1/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
7.4%
7/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
4.5%
3/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
4.3%
4/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Ear and labyrinth disorders
Tinnitus
|
5.3%
5/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
16.4%
11/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
8.7%
8/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Eye disorders
Blurred vision
|
5.3%
5/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
4.5%
3/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
5.4%
5/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Gastrointestinal disorders
Abdominal pain
|
47.4%
45/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
64.2%
43/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
60.9%
56/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Gastrointestinal disorders
Bloating
|
8.4%
8/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
22.4%
15/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
18.5%
17/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Gastrointestinal disorders
Constipation
|
53.7%
51/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
61.2%
41/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
58.7%
54/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
29.5%
28/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
28.4%
19/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
29.3%
27/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Gastrointestinal disorders
Dyspepsia
|
10.5%
10/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
19.4%
13/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
6.5%
6/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
12.6%
12/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
6.0%
4/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
6.5%
6/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Gastrointestinal disorders
Mucositis oral
|
20.0%
19/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
7.5%
5/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
15.2%
14/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Gastrointestinal disorders
Nausea
|
48.4%
46/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
56.7%
38/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
55.4%
51/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Gastrointestinal disorders
Vomiting
|
21.1%
20/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
17.9%
12/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
21.7%
20/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Gastrointestinal disorders
ther gastrointestinal disorders
|
5.3%
5/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
6.0%
4/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
4.3%
4/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
General disorders
Edema limbs
|
7.4%
7/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
10.4%
7/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
8.7%
8/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
General disorders
Fatigue
|
81.1%
77/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
76.1%
51/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
78.3%
72/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
General disorders
Pain
|
18.9%
18/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
16.4%
11/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
12.0%
11/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Metabolism and nutrition disorders
Anorexia
|
23.2%
22/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
26.9%
18/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
22.8%
21/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.9%
18/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
14.9%
10/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
13.0%
12/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.4%
8/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
14.9%
10/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
8.7%
8/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
19/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
19.4%
13/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
13.0%
12/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.6%
12/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
7.5%
5/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
12.0%
11/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Nervous system disorders
Dizziness
|
6.3%
6/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
11.9%
8/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
10.9%
10/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Nervous system disorders
Dysgeusia
|
14.7%
14/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
6.0%
4/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
12.0%
11/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Nervous system disorders
Headache
|
12.6%
12/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
10.4%
7/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
10.9%
10/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Nervous system disorders
Paresthesia
|
12.6%
12/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
10.4%
7/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
16.3%
15/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
54.7%
52/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
46.3%
31/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
46.7%
43/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Psychiatric disorders
Anxiety
|
17.9%
17/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
16.4%
11/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
16.3%
15/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Psychiatric disorders
Depression
|
6.3%
6/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
6.0%
4/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
4.3%
4/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Psychiatric disorders
Insomnia
|
31.6%
30/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
29.9%
20/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
33.7%
31/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Renal and urinary disorders
Urinary incontinence
|
6.3%
6/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.5%
1/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
6.3%
6/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
11.9%
8/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
5.4%
5/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
6.3%
6/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.5%
1/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
5.4%
5/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.4%
8/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
6.0%
4/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
5.4%
5/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.2%
22/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
11.9%
8/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
23.9%
22/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
5/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.5%
1/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
5.4%
5/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Alopecia
|
54.7%
52/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
52.2%
35/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
63.0%
58/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
5/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
3.0%
2/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
2.2%
2/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.3%
6/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
3.0%
2/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
2.2%
2/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Skin and subcutaneous tissue disorders
Other skin and subcutaneous tissue disorders
|
8.4%
8/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
3.0%
2/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
9.8%
9/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Vascular disorders
Flushing
|
2.1%
2/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
10.4%
7/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
6.5%
6/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Vascular disorders
Hot flashes/ flushes
|
17.9%
17/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
14.9%
10/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
12.0%
11/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Vascular disorders
Hypertension
|
9.5%
9/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
7.5%
5/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
6.5%
6/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Gastrointestinal disorders
Abdominal distension
|
2.1%
2/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
14.9%
10/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
6.5%
6/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Gastrointestinal disorders
Flatulence
|
3.2%
3/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
6.0%
4/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
5.4%
5/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
General disorders
Infusion site extravasation
|
2.1%
2/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
7.5%
5/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
2.2%
2/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
General disorders
Other general disorders, administration site conditions
|
4.2%
4/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
9.0%
6/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
6.5%
6/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.1%
2/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
6.0%
4/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Renal and urinary disorders
Urinary frequency
|
2.1%
2/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
7.5%
5/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
3.3%
3/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.1%
2/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
6.0%
4/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
1.1%
1/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.1%
2/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
6.0%
4/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
7.6%
7/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Surgical and medical procedures
Other surgical and medical procedures
|
0.00%
0/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
7.5%
5/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
4.3%
4/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
5.4%
5/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Nervous system disorders
Other nervous system disorders
|
2.1%
2/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
0.00%
0/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
5.4%
5/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
|
Vascular disorders
Thromboembolic event
|
4.2%
4/95 • During the time when patients were treated by protocol therapy, up to 9 months
|
3.0%
2/67 • During the time when patients were treated by protocol therapy, up to 9 months
|
6.5%
6/92 • During the time when patients were treated by protocol therapy, up to 9 months
|
Additional Information
Senior Biostatistician
Canadian Cancer Trials Group
Phone: 6135336430
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place