Trial Outcomes & Findings for Carboplatin Taxol Avastin in Ovarian Cancer (OVCA) (NCT NCT00129727)
NCT ID: NCT00129727
Last Updated: 2016-06-01
Results Overview
Progression Free Survival: To examine the toxicity, estimate the objective response rate, and progression free survival measured in months of carboplatin, paclitaxel, and bevacizumab followed by single agent bevacizumab as consolidation for advanced mullerian cancer
COMPLETED
PHASE2
62 participants
Median PFS in months - up to 5 years
2016-06-01
Participant Flow
Recruitment occurred during the planned time frame. Recruitment occurred at Massachusetts General Hospital; Dana-Farber Cancer Institute; Beth Israel Deaconess Medical Center; and Women and Infants Hospital of Rhode Island.
Participant milestones
| Measure |
Phase II of Carboplatin, Pacitaxel, and Bevacizumab
Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Carboplatin Taxol Avastin in Ovarian Cancer (OVCA)
Baseline characteristics by cohort
| Measure |
Phase II of Carboplatin, Pacitaxel, and Bevacizumab
n=62 Participants
Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=99 Participants
|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 12 • n=99 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Median PFS in months - up to 5 yearsProgression Free Survival: To examine the toxicity, estimate the objective response rate, and progression free survival measured in months of carboplatin, paclitaxel, and bevacizumab followed by single agent bevacizumab as consolidation for advanced mullerian cancer
Outcome measures
| Measure |
Phase II of Carboplatin, Pacitaxel, and Bevacizumab
n=62 Participants
Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
|
|---|---|
|
PFS
|
29.8 Months
Interval 17.3 to
NA = Upper limit not yet reached
|
SECONDARY outcome
Timeframe: 5 yearsTo estimate the objective response rate of carboplatin, paclitaxel, and bevacizumab. Evaluate toxicity.
Outcome measures
| Measure |
Phase II of Carboplatin, Pacitaxel, and Bevacizumab
n=62 Participants
Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
|
|---|---|
|
Response Rate (RECIST-1)
|
76 Percentage of Participants
Interval 69.0 to 87.0
|
SECONDARY outcome
Timeframe: 60 monthsPer CTCAE (Common Toxicity Criteria for Adverse Events) number of participants who experienced toxicity on the study
Outcome measures
| Measure |
Phase II of Carboplatin, Pacitaxel, and Bevacizumab
n=62 Participants
Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
|
|---|---|
|
Toxicity
|
62 Participants
|
Adverse Events
Phase II of Carboplatin, Pacitaxel, and Bevacizumab
Serious adverse events
| Measure |
Phase II of Carboplatin, Pacitaxel, and Bevacizumab
n=62 participants at risk
Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
|
|---|---|
|
Nervous system disorders
Peripheral neuropathy
|
1.6%
1/62 • Number of events 1 • 5 years
CTCAE version 3
|
|
Gastrointestinal disorders
GI perforation
|
1.6%
1/62 • Number of events 1 • 5 years
CTCAE version 3
|
|
Skin and subcutaneous tissue disorders
Wound infection
|
1.6%
1/62 • Number of events 1 • 5 years
CTCAE version 3
|
|
Vascular disorders
Pulmonary embolus
|
3.2%
2/62 • Number of events 2 • 5 years
CTCAE version 3
|
|
General disorders
Hypotension
|
1.6%
1/62 • Number of events 1 • 5 years
CTCAE version 3
|
|
Musculoskeletal and connective tissue disorders
nasal perforation
|
1.6%
1/62 • Number of events 1 • 5 years
CTCAE version 3
|
|
General disorders
abdominal pain
|
1.6%
1/62 • Number of events 1 • 5 years
CTCAE version 3
|
|
Cardiac disorders
SVT
|
1.6%
1/62 • Number of events 1 • 5 years
CTCAE version 3
|
Other adverse events
| Measure |
Phase II of Carboplatin, Pacitaxel, and Bevacizumab
n=62 participants at risk
Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
|
|---|---|
|
Blood and lymphatic system disorders
Hem toxicty
|
1.6%
1/62 • Number of events 1 • 5 years
CTCAE version 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.6%
1/62 • Number of events 1 • 5 years
CTCAE version 3
|
Additional Information
Richard T Penson MD MRCP
Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60