Trial Outcomes & Findings for Radiation Therapy, Paclitaxel, and Cisplatin in Treating Patients With Cancer of the Cervix (NCT NCT00003377)
NCT ID: NCT00003377
Last Updated: 2013-02-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
up to 21 weeks
Results posted on
2013-02-04
Participant Flow
In Period I 12 patients were treated with weekly cisplatin(30-40 mg/m2) and paclitaxel(30-50 mg/m2) concurrent with extended field radiation. In Period II an additional 17 patients were treated with cisplatin 40 mg/m2 and paclitaxel 40 mg/m2 concurrent with radiation.
All patients received whole pelvic and extended field radiation at 150 centigray per day for 30 days to the para-aortics, and 180 centigray per day for 25 days to the pelvis.
Participant milestones
| Measure |
Arm 1, P I
Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
|
Arm 2, P I
Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
|
Arm 3, P I
Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
|
Arm 4, P I
Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
|
Arm 2, P II
Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
|
|---|---|---|---|---|---|
|
Period I
STARTED
|
3
|
3
|
3
|
3
|
0
|
|
Period I
COMPLETED
|
3
|
3
|
2
|
2
|
0
|
|
Period I
NOT COMPLETED
|
0
|
0
|
1
|
1
|
0
|
|
Period II
STARTED
|
0
|
0
|
0
|
0
|
17
|
|
Period II
COMPLETED
|
0
|
0
|
0
|
0
|
16
|
|
Period II
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Arm 1, P I
Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
|
Arm 2, P I
Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
|
Arm 3, P I
Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
|
Arm 4, P I
Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
|
Arm 2, P II
Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
|
|---|---|---|---|---|---|
|
Period I
Dose Limiting Toxicity(DLT)
|
0
|
0
|
1
|
1
|
0
|
|
Period II
Ureteral stent complications
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Radiation Therapy, Paclitaxel, and Cisplatin in Treating Patients With Cancer of the Cervix
Baseline characteristics by cohort
| Measure |
Arm 1, P I
n=3 Participants
Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
|
Arm 2, P I
n=3 Participants
Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
|
Arm 2, P II
n=17 Participants
Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
|
Arm 3, P I
n=3 Participants
Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
|
Arm 4, P I
n=3 Participants
Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
FIGO (International Federation of Gynecology and Obstetrics) Stage
4B - disease spread to distant organs
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
|
Cell Type
Adenocarcinoma NOS(not otherwise specified)
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
2 participants
n=30 Participants
|
|
Cell Type
Clear cell
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
0 participants
n=31 Participants
|
1 participants
n=30 Participants
|
|
Cell Type
Squamous cell
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
16 participants
n=206 Participants
|
2 participants
n=7 Participants
|
3 participants
n=31 Participants
|
26 participants
n=30 Participants
|
|
Age Continuous
|
46.4 years
STANDARD_DEVIATION 13.7 • n=99 Participants
|
54.2 years
STANDARD_DEVIATION 10.7 • n=107 Participants
|
49.8 years
STANDARD_DEVIATION 11.0 • n=206 Participants
|
47.6 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
47.7 years
STANDARD_DEVIATION 4.0 • n=31 Participants
|
49.5 years
STANDARD_DEVIATION 10.1 • n=30 Participants
|
|
Age, Customized
20-29 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
1 participants
n=30 Participants
|
|
Age, Customized
30-39 years
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
2 participants
n=30 Participants
|
|
Age, Customized
40-49 years
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
9 participants
n=206 Participants
|
2 participants
n=7 Participants
|
2 participants
n=31 Participants
|
15 participants
n=30 Participants
|
|
Age, Customized
50-59 years
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
1 participants
n=7 Participants
|
1 participants
n=31 Participants
|
5 participants
n=30 Participants
|
|
Age, Customized
60-69 years
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
6 participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
29 Participants
n=30 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
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
17 participants
n=206 Participants
|
3 participants
n=7 Participants
|
3 participants
n=31 Participants
|
29 participants
n=30 Participants
|
|
FIGO (International Federation of Gynecology and Obstetrics) Stage
1A - disease identified only microscopically
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
|
FIGO (International Federation of Gynecology and Obstetrics) Stage
1B - disease confined to cervix
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
2 participants
n=7 Participants
|
0 participants
n=31 Participants
|
6 participants
n=30 Participants
|
|
FIGO (International Federation of Gynecology and Obstetrics) Stage
2A - no obvious parametrial involvement
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
|
FIGO (International Federation of Gynecology and Obstetrics) Stage
2B - obvious parametrial involvement
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
4 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
7 participants
n=30 Participants
|
|
FIGO (International Federation of Gynecology and Obstetrics) Stage
3A -disease in lower 3rd of vagina not pelvic wall
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
|
FIGO (International Federation of Gynecology and Obstetrics) Stage
3B - disease extended to pelvic wall
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
7 participants
n=206 Participants
|
1 participants
n=7 Participants
|
2 participants
n=31 Participants
|
12 participants
n=30 Participants
|
|
FIGO (International Federation of Gynecology and Obstetrics) Stage
4A - disease spread to adjacent organs
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
4 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
4 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: up to 21 weeksOutcome measures
| Measure |
Arm 1, P I
n=3 Participants
Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
|
Arm 2, P I
n=3 Participants
Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
|
Arm 3, P I
n=3 Participants
Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
|
Arm 4, P I
n=3 Participants
Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
|
Arm 2, PII
n=17 Participants
Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
|
|---|---|---|---|---|---|
|
Dose Limiting Toxicity(DLT)/Significant Dose Delay of Paclitaxel With Cisplatin as Assessed by CTC 2.0 After 6 Cycles of Treatment
Dose Limiting Toxicity(DLT)/Significant Dose Delay
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
0 participants
|
|
Dose Limiting Toxicity(DLT)/Significant Dose Delay of Paclitaxel With Cisplatin as Assessed by CTC 2.0 After 6 Cycles of Treatment
Complications unrelated to treatment
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 2 yearsProduct-limit estimate of the probability of being alive and progression-free at 24 months based on those 20 patients who were treated at the study recommended dose level (RDL) is 0.65, 95% confidence interval (0.44-0.86). Progression is defined as a 50% or greater increase in the product from any lesion documented within eight weeks for study entry or the appearance of any new lesion within eight weeks of entry into study.
Outcome measures
| Measure |
Arm 1, P I
n=20 Participants
Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
|
Arm 2, P I
Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
|
Arm 3, P I
Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
|
Arm 4, P I
Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
|
Arm 2, PII
Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
|
|---|---|---|---|---|---|
|
Disease-free Survival at 2 Years
|
0.65 probability
Interval 0.44 to 0.86
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 yearsProduct-limit estimate of the probability of being alive at 24 months based on those 20 patients who were treated at the study recommended dose-level is 0.80, 95 % confidence interval (0.62-0.97)
Outcome measures
| Measure |
Arm 1, P I
n=20 Participants
Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
|
Arm 2, P I
Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
|
Arm 3, P I
Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
|
Arm 4, P I
Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
|
Arm 2, PII
Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
|
|---|---|---|---|---|---|
|
Overall Survival at 2 Years
|
0.80 probability
Interval 0.62 to 0.97
|
—
|
—
|
—
|
—
|
Adverse Events
Arm 1, P I
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2, P I
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 3, P I
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 4, P I
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm 2, P II
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1, P I
n=3 participants at risk
Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
|
Arm 2, P I
n=3 participants at risk
Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
|
Arm 3, P I
n=3 participants at risk
Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
|
Arm 4, P I
n=3 participants at risk
Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
|
Arm 2, P II
n=17 participants at risk
Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
|
|---|---|---|---|---|---|
|
Cardiac disorders
Pulmonary disorders
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Nausea and vomiting
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hypomagnesia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.9%
1/17 • Number of events 1
|
Other adverse events
| Measure |
Arm 1, P I
n=3 participants at risk
Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
|
Arm 2, P I
n=3 participants at risk
Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
|
Arm 3, P I
n=3 participants at risk
Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
|
Arm 4, P I
n=3 participants at risk
Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
|
Arm 2, P II
n=17 participants at risk
Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
41.2%
7/17
|
|
Blood and lymphatic system disorders
Leukopenia
|
66.7%
2/3
|
100.0%
3/3
|
33.3%
1/3
|
33.3%
1/3
|
58.8%
10/17
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
11.8%
2/17
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
5.9%
1/17
|
|
Cardiac disorders
Pulmonary Embolism
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
5.9%
1/17
|
|
Cardiac disorders
Hypotension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.9%
1/17
|
|
General disorders
Fatigue
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
17.6%
3/17
|
|
Gastrointestinal disorders
Nausea and vomiting
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
23.5%
4/17
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
17.6%
3/17
|
|
General disorders
Vaginal Bleeding
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.9%
1/17
|
|
Infections and infestations
Febrile neutropenia
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
17.6%
3/17
|
|
Metabolism and nutrition disorders
Hypomagnesia
|
33.3%
1/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
33.3%
1/3
|
17.6%
3/17
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.9%
1/17
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
5.9%
1/17
|
|
Nervous system disorders
Seizure
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/17
|
|
Nervous system disorders
Confusion
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/17
|
|
General disorders
Pelvic pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.9%
1/17
|
|
General disorders
Abdominal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.9%
1/17
|
|
Hepatobiliary disorders
ALT
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.9%
1/17
|
|
Vascular disorders
Prothrombin time
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.9%
1/17
|
Additional Information
Melissa Leventhal
Gynecologic Oncology Group Statistical & Data Center
Phone: (716)845-5702
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place