Trial · NCT00262847
Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
NCT00262847, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2013-09-18
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer. Trials, record NCT00262847. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00262847
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
- NCT number
- NCT00262847
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,873 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma, Malignant Ovarian Mixed Epithelial Tumor, Ovarian Brenner Tumor, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mucinous Adenocarcinoma, Ovarian Serous Adenocarcinoma, Ovarian Transitional Cell Carcinoma, Primary Peritoneal Serous Adenocarcinoma, Stage IIIA Fallopian Tube Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Primary Peritoneal Cancer, Stage IIIB Fallopian Tube Cancer, Stage IIIB Ovarian Cancer, Stage IIIB Primary Peritoneal Cancer, Stage IIIC Fallopian Tube Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Primary Peritoneal Cancer, Stage IV Fallopian Tube Cancer, Stage IV Ovarian Cancer, Stage IV Primary Peritoneal Cancer, Undifferentiated Fallopian Tube Carcinoma, Undifferentiated Ovarian Carcinoma
- Interventions
- Bevacizumab, Carboplatin, Laboratory Biomarker Analysis, Paclitaxel, Placebo, Quality-of-Life Assessment
- First posted
- 2005-12-07
- Last updated
- 2019-07-23
- Results first posted
- 2013-09-18
- Limitations and caveats
- The results for both Overall Survival (OS) and Progression Free Survival (PFS) were based on the analysis performed on a data set frozen on August 26, 2011.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | From study entry until first disease progression, death or date of last contact, up to 6 years | Median progression-free survival (PFS). Onset of progression could be based on radiographic (RECIST) criteria or rising CA-125 (GCIG criteria). |
| Secondary | Overall Survival | From study entry to death or last contact, up to 6 years | Median overall survival (OS) |
| Secondary | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Up to 5 years | Eligible and Evaluable patients |
| Secondary | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | At baseline, 9, 18, 36, 60, and 84 weeks | Estimated least squares means from a mixed module of Quality of Life (QOL) scores at each assessment point, adjusted for baseline score and patient's age. Note: The range of possible scores of the FACT-O TOI is 0 - 104 for all treatment groups and at all visits. A higher score indicates better QOL. Baseline mean scores are raw means. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | From study entry until first disease progression, death or date of last contact, up to 6 years | months | MEDIAN | |
| SECONDARY | Overall Survival | From study entry to death or last contact, up to 6 years | months | MEDIAN | |
| SECONDARY | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Up to 5 years | Eligible and evaluable patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | At baseline, 9, 18, 36, 60, and 84 weeks | Number of valid QOL assessments do not total number of patients randomized in study. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group111
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Arm I (Placebo, Paclitaxel, Carboplatin) | 11.0 | 95% Confidence Interval 10.2 to 12.0 | months | |
| Progression-free Survival | Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | 12.3 | 95% Confidence Interval 11.4 to 12.8 | months | |
| Progression-free Survival | Arm III (Paclitaxel, Carboplatin, Bevacizumab) | 15.3 | 95% Confidence Interval 14.2 to 16.1 | months | |
| Overall Survival | Arm I (Placebo, Paclitaxel, Carboplatin) | 40.6 | 95% Confidence Interval 37.1 to 45.5 | months | |
| Overall Survival | Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | 38.7 | 95% Confidence Interval 35.2 to 42.1 | months | |
| Overall Survival | Arm III (Paclitaxel, Carboplatin, Bevacizumab) | 43.8 | 95% Confidence Interval 39.7 to 49.0 | months | |
| Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Arm I Toxicities (Placebo, Paclitaxel, Carboplatin) | White blood cell | 317 | Participants | |
| Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab) | White blood cell | 328 | Participants | |
| Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab) | White blood cell | 327 | Participants | |
| Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Arm I Toxicities (Placebo, Paclitaxel, Carboplatin) | Absolute neutrophil count | 540 | Participants |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Placebo, Paclitaxel, Carboplatin) | 625 | |
| Overall Study | STARTED | Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | 625 | |
| Overall Study | STARTED | Arm III (Paclitaxel, Carboplatin, Bevacizumab) | 623 | |
| Overall Study | COMPLETED | Arm I (Placebo, Paclitaxel, Carboplatin) | 107 | |
| Overall Study | COMPLETED | Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | 112 | |
| Overall Study | COMPLETED | Arm III (Paclitaxel, Carboplatin, Bevacizumab) | 227 | |
| Overall Study | NOT COMPLETED | Arm I (Placebo, Paclitaxel, Carboplatin) | 518 | |
| Overall Study | NOT COMPLETED | Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | 513 | |
| Overall Study | NOT COMPLETED | Arm III (Paclitaxel, Carboplatin, Bevacizumab) | 396 |
Source ClinicalTrials.gov
Adverse events750
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 | Allergic Reaction/Hypersensitivity | Immune system disorders | Arm I (Placebo, Paclitaxel, Carboplatin) | 56 | 621 | |
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | 65 | 624 | |
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Arm III (Paclitaxel, Carboplatin, Bevacizumab) | 68 | 619 | |
| other | Rhinitis | Immune system disorders | Arm I (Placebo, Paclitaxel, Carboplatin) | 67 | 621 | |
| other | Rhinitis | Immune system disorders | Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | 93 | 624 | |
| other | Rhinitis | Immune system disorders | Arm III (Paclitaxel, Carboplatin, Bevacizumab) | 98 | 619 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm I (Placebo, Paclitaxel, Carboplatin) | 28 | 621 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | 18 | 624 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm III (Paclitaxel, Carboplatin, Bevacizumab) | 32 | 619 | |
| other | Neutrophils | Blood and lymphatic system disorders | Arm I (Placebo, Paclitaxel, Carboplatin) | 589 | 621 |
1 to 10 of 750Source ClinicalTrials.gov
See all 750 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Placebo, Paclitaxel, Carboplatin) | ||
| Total, all-cause mortality | Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | ||
| Total, all-cause mortality | Arm III (Paclitaxel, Carboplatin, Bevacizumab) | ||
| Total, other adverse events | Arm I (Placebo, Paclitaxel, Carboplatin) | 589 | 621 |
| Total, other adverse events | Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | 593 | 624 |
| Total, other adverse events | Arm III (Paclitaxel, Carboplatin, Bevacizumab) | 588 | 619 |
| Total, serious adverse events | Arm I (Placebo, Paclitaxel, Carboplatin) | 239 | 621 |
| Total, serious adverse events | Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | 257 | 624 |
| Total, serious adverse events | Arm III (Paclitaxel, Carboplatin, Bevacizumab) | 287 | 619 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA027469 | Gynecologic Oncology Group | DISAIA, PHILIP J. | GYNECOLOGIC ONCOLOGY GROUP | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00262847
GET https://conductscience.org/api/trials/v1/NCT00262847/results?page=2