Trial · NCT00434642
A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma
NCT00434642, Phase 3, Completed, Genentech, Inc.; results first posted 2011-11-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma. Trials, record NCT00434642. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00434642
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma
- NCT number
- NCT00434642
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 484 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Ovarian Cancer
- Interventions
- Carboplatin, Gemcitabine, Bevacizumab, Placebo
- First posted
- 2007-02-13
- Last updated
- 2017-08-09
- Results first posted
- 2011-11-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) | From randomization through September 17, 2010 (up to 3 years, 5 months) | PFS was defined as the time from randomization to disease progression (PD), as determined by the investigator, or death due to any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started; the appearance of 1 or more new lesions; and/or the unequivocal progression of existing non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks. |
| Secondary | Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) | From randomization through September 17, 2010 (up to 3 years, 5 months) | An objective response was the occurrence of either a partial response (PR) or complete response (CR). PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. CR: The disappearance of all target and non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks. |
| Secondary | Duration of Objective Response (OR) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) | From randomization through September 17, 2010 (up to 3 years, 5 months) | Duration of OR was analyzed in the subset of patients who achieved an OR. The duration of OR was defined as the time from the initial CR or PR until documented PD or death. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks. |
| Secondary | Overall Survival | From randomization through July 19, 2013 (up to 6 years, 3 months) | Overall survival was defined as the time from randomization to death from any cause. |
| Secondary | Percentage of Patients Who Had a Gastrointestinal Perforation (GIP) | From randomization through September 17, 2010 (up to 3 years, 5 months) | A gastrointestinal perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder. |
| Secondary | Percentage of Patients Who Had at Least 1 Adverse Event | From randomization through July 19, 2013 (up to 6 years, 3 months) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) | From randomization through September 17, 2010 (up to 3 years, 5 months) | Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group). | Months | MEDIAN |
| SECONDARY | Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) | From randomization through September 17, 2010 (up to 3 years, 5 months) | Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group). | Percentage of participants | NUMBER |
| SECONDARY | Duration of Objective Response (OR) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) | From randomization through September 17, 2010 (up to 3 years, 5 months) | Subset of the intent-to-treat population: All patients randomized to treatment who achieved an objective response. | Months | MEDIAN |
| SECONDARY | Overall Survival | From randomization through July 19, 2013 (up to 6 years, 3 months) | Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group). | Months | MEDIAN |
| SECONDARY | Percentage of Patients Who Had a Gastrointestinal Perforation (GIP) | From randomization through September 17, 2010 (up to 3 years, 5 months) | Safety population: All patients who received at least 1 dose of protocol treatment. Due to errors in drug administration, the safety population included 247 patients in the carboplatin and gemcitabine + bevacizumab group and 233 patients in the carboplatin and gemcitabine + placebo group. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Who Had at Least 1 Adverse Event | From randomization through July 19, 2013 (up to 6 years, 3 months) | Safety population: All patients who received at least 1 dose of protocol treatment. Due to errors in drug administration, the safety population included 247 patients in the carboplatin and gemcitabine + bevacizumab group and 233 patients in the carboplatin and gemcitabine + placebo group. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) | Carboplatin and Gemcitabine + Bevacizumab | 12.4 | 95% Confidence Interval 11.40 to 12.71 | Months | |
| Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) | Carboplatin and Gemcitabine + Placebo | 8.4 | 95% Confidence Interval 8.31 to 9.66 | Months | |
| Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) | Carboplatin and Gemcitabine + Bevacizumab | 78.5 | Percentage of participants | ||
| Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) | Carboplatin and Gemcitabine + Placebo | 57.4 | Percentage of participants | ||
| Duration of Objective Response (OR) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) | Carboplatin and Gemcitabine + Bevacizumab | 10.4 | 95% Confidence Interval 9.36 to 11.83 | Months | |
| Duration of Objective Response (OR) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) | Carboplatin and Gemcitabine + Placebo | 7.4 | 95% Confidence Interval 6.31 to 8.31 | Months | |
| Overall Survival | Carboplatin and Gemcitabine + Bevacizumab | 33.6 | 95% Confidence Interval 30.32 to 35.84 | Months | |
| Overall Survival | Carboplatin and Gemcitabine + Placebo | 32.9 | 95% Confidence Interval 29.80 to 37.68 | Months | |
| Percentage of Patients Who Had a Gastrointestinal Perforation (GIP) | Carboplatin and Gemcitabine + Bevacizumab | 0 | Percentage of participants | ||
| Percentage of Patients Who Had a Gastrointestinal Perforation (GIP) | Carboplatin and Gemcitabine + Placebo | 0 | Percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Blinded Treatment Phase | STARTED | Carboplatin and Gemcitabine + Placebo | 242 | |
| Blinded Treatment Phase | STARTED | Carboplatin and Gemcitabine + Bevacizumab | 242 | |
| Blinded Treatment Phase | COMPLETED | Carboplatin and Gemcitabine + Placebo | 0 | |
| Blinded Treatment Phase | COMPLETED | Carboplatin and Gemcitabine + Bevacizumab | 13 | |
| Blinded Treatment Phase | NOT COMPLETED | Carboplatin and Gemcitabine + Placebo | 242 | |
| Blinded Treatment Phase | NOT COMPLETED | Carboplatin and Gemcitabine + Bevacizumab | 229 | |
| Open-label Treatment Phase | STARTED | Carboplatin and Gemcitabine + Placebo | 0 | |
| Open-label Treatment Phase | STARTED | Carboplatin and Gemcitabine + Bevacizumab | 12 | |
| Open-label Treatment Phase | COMPLETED | Carboplatin and Gemcitabine + Placebo | 0 | |
| Open-label Treatment Phase | COMPLETED | Carboplatin and Gemcitabine + Bevacizumab | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events402
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Carboplatin and Gemcitabine + Bevacizumab | 126 | 247 | |
| other | Anaemia | Blood and lymphatic system disorders | Carboplatin and Gemcitabine + Placebo | 137 | 233 | |
| other | Leukopenia | Blood and lymphatic system disorders | Carboplatin and Gemcitabine + Bevacizumab | 36 | 247 | |
| other | Leukopenia | Blood and lymphatic system disorders | Carboplatin and Gemcitabine + Placebo | 32 | 233 | |
| other | Neutropenia | Blood and lymphatic system disorders | Carboplatin and Gemcitabine + Bevacizumab | 172 | 247 | |
| other | Neutropenia | Blood and lymphatic system disorders | Carboplatin and Gemcitabine + Placebo | 158 | 233 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Carboplatin and Gemcitabine + Bevacizumab | 135 | 247 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Carboplatin and Gemcitabine + Placebo | 111 | 233 | |
| other | Tinnitus | Ear and labyrinth disorders | Carboplatin and Gemcitabine + Bevacizumab | 14 | 247 | |
| other | Tinnitus | Ear and labyrinth disorders | Carboplatin and Gemcitabine + Placebo | 11 | 233 |
1 to 10 of 402Source ClinicalTrials.gov
See all 402 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Carboplatin and Gemcitabine + Bevacizumab | ||
| Total, all-cause mortality | Carboplatin and Gemcitabine + Placebo | ||
| Total, other adverse events | Carboplatin and Gemcitabine + Bevacizumab | 246 | 247 |
| Total, other adverse events | Carboplatin and Gemcitabine + Placebo | 233 | 233 |
| Total, serious adverse events | Carboplatin and Gemcitabine + Bevacizumab | 90 | 247 |
| Total, serious adverse events | Carboplatin and Gemcitabine + Placebo | 59 | 233 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Carboplatin and Gemcitabine + Bevacizumab vs Carboplatin and Gemcitabine + Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00434642
GET https://conductscience.org/api/trials/v1/NCT00434642/events?page=2