Trial Outcomes & Findings for Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer (NCT NCT00267696)
NCT ID: NCT00267696
Last Updated: 2015-04-30
Results Overview
Progression-free survival (PFS) by RECIST, and safety. RECIST verison 1.0 was used for the assessment of progression and was based on radiologic evaluation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
up to 6 months
Results posted on
2015-04-30
Participant Flow
February 2006 through August 2010
Participant milestones
| Measure |
Gemcitabine/Carboplatin/Bevacizumab
A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle
Carboplatin
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine/Carboplatin/Bevacizumab
n=45 Participants
A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administred on day 1 and day 15 of a 28 day cycle
Carboplatin
|
|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 8.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
45 patients
n=99 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Performance Status
0 (Fully active)
|
34 patients
n=99 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Performance Status
1 (Restricted in physical activity)
|
11 patients
n=99 Participants
|
|
Primary disease site
Ovarian
|
40 patients
n=99 Participants
|
|
Primary disease site
Primary peritoneal
|
4 patients
n=99 Participants
|
|
Primary disease site
Tubal
|
1 patients
n=99 Participants
|
|
Primary disease stage
Stage 1-2 (cancer located in ovaries or pelvis)
|
7 patients
n=99 Participants
|
|
Primary disease stage
Stage 3 (cancer in ovaries spread to peritoneum)
|
34 patients
n=99 Participants
|
|
Primary disease stage
Stage 4 (cancer has spread to distant organs)
|
4 patients
n=99 Participants
|
|
Primary disease grade
G2(tissue moderately differentiated)
|
3 patients
n=99 Participants
|
|
Primary disease grade
G3(tissue poorly differentiated/undifferentiated)
|
42 patients
n=99 Participants
|
|
Platinum-free interval
|
15 months
n=99 Participants
|
|
Disease status at study enrollment
Measurable disease
|
33 patients
n=99 Participants
|
|
Disease status at study enrollment
Non-measurable disease (CA125)
|
12 patients
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 6 monthsProgression-free survival (PFS) by RECIST, and safety. RECIST verison 1.0 was used for the assessment of progression and was based on radiologic evaluation.
Outcome measures
| Measure |
Gemcitabine/Carboplatin/Bevacizumab
n=45 Participants
A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle
Carboplatin
|
|---|---|
|
Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding.
|
13.3 months
Interval 11.3 to 15.3
|
SECONDARY outcome
Timeframe: To progression of DiseaseThe period of time from study entry until disease progression or date of last contact.
Outcome measures
| Measure |
Gemcitabine/Carboplatin/Bevacizumab
n=45 Participants
A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle
Carboplatin
|
|---|---|
|
Overall Survival for Patients Treated With the Regimen.
|
36.1 months
Interval 26.7 to 45.5
|
Adverse Events
Gemcitabine/Carboplatin/Bevacizumab
Serious events: 4 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine/Carboplatin/Bevacizumab
n=45 participants at risk
A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle
Carboplatin
|
|---|---|
|
Vascular disorders
Deep Vein Thrombosis
|
4.4%
2/45 • Number of events 2 • Toxicity was graded according to the CTCAE-3. Patients were observed for adverse events fro 30 days after treatment discontinuation, and for survival every 3 months until death.
|
|
Vascular disorders
Cerebrovascular events
|
4.4%
2/45 • Number of events 2 • Toxicity was graded according to the CTCAE-3. Patients were observed for adverse events fro 30 days after treatment discontinuation, and for survival every 3 months until death.
|
Other adverse events
| Measure |
Gemcitabine/Carboplatin/Bevacizumab
n=45 participants at risk
A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle
Carboplatin
|
|---|---|
|
Blood and lymphatic system disorders
Hematologic
|
86.7%
39/45 • Number of events 39 • Toxicity was graded according to the CTCAE-3. Patients were observed for adverse events fro 30 days after treatment discontinuation, and for survival every 3 months until death.
|
Additional Information
Larry Copeland, MD
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-8697
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place