Trial · NCT00951496
Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
NCT00951496, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2018-05-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer. Trials, record NCT00951496. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00951496
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
- NCT number
- NCT00951496
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,560 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, Fallopian Tube Undifferentiated Carcinoma, Malignant Ovarian Brenner Tumor, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mucinous Adenocarcinoma, Ovarian Seromucinous Carcinoma, Ovarian Serous Adenocarcinoma, Ovarian Transitional Cell Carcinoma, Ovarian Undifferentiated Carcinoma, Primary Peritoneal Clear Cell Adenocarcinoma, Primary Peritoneal Endometrioid Adenocarcinoma, Primary Peritoneal Serous Adenocarcinoma, Primary Peritoneal Transitional Cell Carcinoma, Primary Peritoneal Undifferentiated Carcinoma, Stage II Fallopian Tube Cancer AJCC v6 and v7, Stage II Ovarian Cancer AJCC v6 and v7, Stage IIA Fallopian Tube Cancer AJCC v6 and v7, Stage IIA Ovarian Cancer AJCC V6 and v7, Stage IIB Fallopian Tube Cancer AJCC v6 and v7, Stage IIB Ovarian Cancer AJCC v6 and v7, Stage IIC Fallopian Tube Cancer AJCC v6 and v7, Stage IIC Ovarian Cancer AJCC v6 and v7, Stage III Ovarian Cancer AJCC v6 and v7, Stage III Primary Peritoneal Cancer AJCC v7, Stage IIIA Ovarian Cancer AJCC v6 and v7, Stage IIIA Primary Peritoneal Cancer AJCC v7, Stage IIIB Ovarian Cancer AJCC v6 and v7, Stage IIIB Primary Peritoneal Cancer AJCC v7, Stage IIIC Ovarian Cancer AJCC v6 and v7, Stage IIIC Primary Peritoneal Cancer AJCC v7, Stage IV Fallopian Tube Cancer AJCC v6 and v7, Stage IV Ovarian Cancer AJCC v6 and v7, Stage IV Primary Peritoneal Cancer AJCC v7
- Interventions
- Bevacizumab, Carboplatin, Carboplatin, Cisplatin, Laboratory Biomarker Analysis, Paclitaxel, Paclitaxel, Quality-of-Life Assessment
- First posted
- 2009-08-04
- Last updated
- 2026-06-02
- Results first posted
- 2018-05-18
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Progression-free Survival | Progression-free survival is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years. | Estimate the median duration of progression-free survival in months. Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0 | During treatment and up to 30 days after end of treatment | Eligible and treated patients. CTCAE includes grades 1-5. Grade refers to the severity of the adverse event. Grades 0 listed should be interpreted to mean there were no subjects in the arm with a toxicity to report. Grade 1 toxicities are mild; asymptomatic or mild symptoms. Grade 2 toxicities are moderate; minimal, local or noninvasive intervention indicated. Grade 3 toxicities are severe or medically significant but not immediately life-threatening. Grade 4 toxicities are life threatening. Grade 5 is death related to adverse event. |
| Secondary | Overall Survival | Up to 10 years | Estimate the median duration of overall survival in months. |
| Secondary | Patient Reported Quality of Life (QOL) | Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, up to 84 weeks post starting treatment | QOL was measured with the FACT-O TOI score. Means at baseline are raw means. Scores are reported at all time points in the outcome measure table. FACT-O TOI is Trial outcome index (TOI) of the Functional assessment of cancer therapy (FACT) for ovarian cancer (FACT-O). The FACT-O TOI is composed of three subscales; Physical Well Being (PWB) ( 7 items), and Ovarian Cancer subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5 point scale (0=not at all; 1=a little bit; 2=somewhat;3=quite a bit;4=very much). A subscale score is computed as long as more thatn 50% of subscale items have been answered. A total score of the FACT-O items provide valid responses and all three subscales have valid scores. A score of the FACT-) TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL). |
| Secondary | Patient Reported Neurotoxicity (Ntx) | Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment | The FACT/GOG-NTX subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5 point Likert scale (0=not at all; 1=a little bit;2=somewhat;3=quite a bit; 4=very much). For each item, reversal was performed prior to score calculation so that a large score suggests less symptoms. According to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of a subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges from 0-16 with a large subscale score suggesting less symptom or better QOL. |
| Secondary | Patient Reported Fatigue | Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment | Patient reported fatigue as measured with the Functional Assessment of Chronic Illness Therapy- Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue contains 13 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Fatigue score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The FACIT-Fatigue score ranges 0-52 with a large score suggesting less fatigue. |
| Secondary | Patient Reported Nausea | Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment | Nausea was measured with the a single item ,' I have nausea' from the FACT-O TOI, and was scored using a 5 point scale (0=not at all; 1=a little bit; 2=somewhat;3=quite a bit;4=very much) |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Progression-free Survival | Progression-free survival is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years. | Intention-to-treat: All enrolled patients | months | MEDIAN |
| SECONDARY | Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0 | During treatment and up to 30 days after end of treatment | Treated Patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | Up to 10 years | Intention-to-treat: All enrolled patients | Months | MEDIAN |
| SECONDARY | Patient Reported Quality of Life (QOL) | Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, up to 84 weeks post starting treatment | Patients evaluable for PRO (Patient Reported Outcomes)/QOL (completed baseline and at least one follow-up assessment) | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Reported Neurotoxicity (Ntx) | Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment | Patients evaluable for PRO(Patient Reported Outcome)/QOL (completed baseline and at least one follow-up assessment). | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Reported Fatigue | Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment | Patients evaluable for PRO (Patient Reported Outcomes)/QOL. Evaluable patients have completed baseline and at least one follow-up assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Reported Nausea | Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment | Patients evaluable for PRO (Patient Reported Outcomes)/QOL are patients who completed baseline and at least one follow-up assessment | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Progression-free Survival | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | 24.9 | 95% Confidence Interval 22.3 to 27.2 | months | |
| Median Progression-free Survival | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | 27.3 | 95% Confidence Interval 24.6 to 28.8 | months | |
| Median Progression-free Survival | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) | 26.0 | 95% Confidence Interval 23.8 to 28.0 | months | |
| Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0 | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | Adverse Event Grade 0 | 0 | Participants | |
| Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0 | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | Adverse Event Grade 0 | 0 | Participants | |
| Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0 | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) | Adverse Event Grade 0 | 1 | Participants | |
| Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0 | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | Adverse Event Grade 1 | 1 | Participants | |
| Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0 | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | Adverse Event Grade 1 | 0 | Participants | |
| Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0 | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) | Adverse Event Grade 1 | 0 | Participants | |
| Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0 | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | Adverse Event Grade 2 | 48 | Participants |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 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 (Paclitaxel, Carboplatin, Bevcizumab IV) | 521 | |
| Overall Study | STARTED | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | 518 | |
| Overall Study | STARTED | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) | 521 | |
| Overall Study | COMPLETED | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | 511 | |
| Overall Study | COMPLETED | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | 510 | |
| Overall Study | COMPLETED | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) | 508 | |
| Overall Study | NOT COMPLETED | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | 10 | |
| Overall Study | NOT COMPLETED | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | 8 | |
| Overall Study | NOT COMPLETED | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) | 13 |
Source ClinicalTrials.gov
Adverse events2,079
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 | Allergy/Immunology - Other | Immune system disorders | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | 3 | 511 | |
| other | Allergy/Immunology - Other | Immune system disorders | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | 1 | 510 | |
| other | Allergy/Immunology - Other | Immune system disorders | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) | 1 | 508 | |
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | 36 | 511 | |
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | 51 | 510 | |
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) | 54 | 508 | |
| other | Vasculitis | Immune system disorders | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | 0 | 511 | |
| other | Vasculitis | Immune system disorders | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | 1 | 510 | |
| other | Vasculitis | Immune system disorders | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) | 1 | 508 | |
| other | Rhinitis | Immune system disorders | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | 141 | 511 |
1 to 10 of 2,079Source ClinicalTrials.gov
See all 2,079 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | ||
| Total, all-cause mortality | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | ||
| Total, all-cause mortality | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) | ||
| Total, other adverse events | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | 511 | 511 |
| Total, other adverse events | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | 510 | 510 |
| Total, other adverse events | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) | 507 | 508 |
| Total, serious adverse events | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | 156 | 511 |
| Total, serious adverse events | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | 179 | 510 |
| Total, serious adverse events | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) | 215 | 508 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31002578 | DERIVED |
Source PubMed
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/NCT00951496
GET https://conductscience.org/api/trials/v1/NCT00951496/results?page=2