Trial · NCT00565851
Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
NCT00565851, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2020-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer. Trials, record NCT00565851. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00565851
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
- NCT number
- NCT00565851
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 1,052 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Clear Cell Adenocarcinoma, 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, Mucinous Adenocarcinoma, Ovarian Brenner Tumor, Ovarian Clear Cell Adenocarcinofibroma, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid 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, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Undifferentiated Carcinoma
- Interventions
- Bevacizumab, Carboplatin, Docetaxel, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Paclitaxel, Quality-of-Life Assessment
- First posted
- 2007-11-30
- Last updated
- 2025-12-30
- Results first posted
- 2020-12-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer | The time frame is 82.5 months (median duration of follow-up) | The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs \> 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method. |
| Primary | To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer | The time frame is 82.5 months (median duration of follow-up). | The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs \> 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method. |
| Secondary | Progression-free Survival (Chemotherapy Analysis) | Radiographic assessment of disease was conducted during chemotherapy and then every 6 months during the maintenance / surveillance phase | Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause. |
| Secondary | Progression Free Survival (Surgery Analysis) | Radiographic assessment of disease (in patients with measurable and non-measurable disease) was conducted Every three months for two years and then every 6 months after completion of chemotherapy during the maintenance/surveillance phase. | Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause. |
| Secondary | Summary of Adverse Events (CTCAE Version 4.0) | During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months | Number of treated patients with at least one adverse event reported (assessed by Common Terminology Criteria for Adverse Events (version 4.0)) |
| Secondary | Patient Reported Quality of Life (Chemotherapy Analysis) | 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1. | Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL. |
| Secondary | Patient Reported Physical Function (Chemotherapy Analysis) | 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1. | Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning Subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning. |
| Secondary | Patient Reported Quality of Life (Surgery Analysis) | 1. Prior to surgery, 2. 6 weeks post-surgery, 3. 15 weeks post-surgery, 4. 6 months post-surgery, 5. 12 months post-surgery. | Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL. |
| Secondary | Patient Reported Physical Functioning (Surgery Analysis) | 1. Prior to surgery (baseline), 2. 6 weeks post-surgery, 3. 15 weeks post-surgery 4. 6 months post-surgery, 5. 12 months post-surgery | Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning. This measure was completed by US patients only. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer | The time frame is 82.5 months (median duration of follow-up) | All patients who were eligible for the surgery analysis (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol) | Months | MEDIAN |
| PRIMARY | To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer | The time frame is 82.5 months (median duration of follow-up). | All patients who were enrolled between December 10, 2007 and August 26, 2011 and received paclitaxel and carboplatin (with or without bevacizumab) (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol). | Months | MEDIAN |
| SECONDARY | Progression-free Survival (Chemotherapy Analysis) | Radiographic assessment of disease was conducted during chemotherapy and then every 6 months during the maintenance / surveillance phase | All patients who were enrolled and eligible for the chemotherapy analysis (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol). | Months | MEDIAN |
| SECONDARY | Progression Free Survival (Surgery Analysis) | Radiographic assessment of disease (in patients with measurable and non-measurable disease) was conducted Every three months for two years and then every 6 months after completion of chemotherapy during the maintenance/surveillance phase. | All randomized patients who were eligible for the surgery analysis (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol). | Months | MEDIAN |
| SECONDARY | Summary of Adverse Events (CTCAE Version 4.0) | During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months | Eligible and treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Reported Quality of Life (Chemotherapy Analysis) | 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1. | Provided baseline and at least one follow-up assessment (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol). | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Reported Physical Function (Chemotherapy Analysis) | 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1. | Provided baseline and at least one follow-up assessments (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol). | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Reported Quality of Life (Surgery Analysis) | 1. Prior to surgery, 2. 6 weeks post-surgery, 3. 15 weeks post-surgery, 4. 6 months post-surgery, 5. 12 months post-surgery. | Provided baseline and at least one follow-up assessment (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol). | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Reported Physical Functioning (Surgery Analysis) | 1. Prior to surgery (baseline), 2. 6 weeks post-surgery, 3. 15 weeks post-surgery 4. 6 months post-surgery, 5. 12 months post-surgery | US patients who provided baseline and ≥ 1 follow-up assessments (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol). | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer | No Cytoreductive Surgery | 64.7 | 95% Confidence Interval 54.5 to 73.9 | Months | |
To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer | Cytoreductive Surgery | 50.6 | 95% Confidence Interval 44.2 to 59.7 | Months | |
To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer | Paclitaxel and Carboplatin Chemotherapy | 37.3 | 95% Confidence Interval 32.6 to 39.7 | Months | |
To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer | Paclitaxel and Carboplatin Chemotherapy With Bevacizumab | 42.2 | 95% Confidence Interval 37.7 to 46.2 | Months | |
| Progression-free Survival (Chemotherapy Analysis) | Paclitaxel and Carboplatin Chemotherapy | 10.4 | 95% Confidence Interval 9.7 to 11.0 | Months | |
| Progression-free Survival (Chemotherapy Analysis) | Paclitaxel and Carboplatin Chemotherapy With Bevacizumab | 13.8 | 95% Confidence Interval 13.0 to 14.7 | Months | |
| Progression Free Survival (Surgery Analysis) | No Cytoreductive Surgery | 16.2 | 95% Confidence Interval 14.2 to 19.6 | Months | |
| Progression Free Survival (Surgery Analysis) | Cytoreductive Surgery | 18.9 | 95% Confidence Interval 16.8 to 21.0 | Months | |
| Summary of Adverse Events (CTCAE Version 4.0) | Arm I (no Surgery; Carboplatin and Paclitaxel) | 304 | Participants | ||
| Summary of Adverse Events (CTCAE Version 4.0) | Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) | 376 | Participants |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow88
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Surgical Assignment | STARTED | Arm I (no Surgery; Carboplatin and Paclitaxel) | 316 | |
| Surgical Assignment | STARTED | Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) | 456 | |
| Surgical Assignment | STARTED | Arm III (Surgery; Carboplatin and Paclitaxel) | 33 | |
| Surgical Assignment | STARTED | Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab) | 165 | |
| Surgical Assignment | STARTED | Arm V (no Surgery; Carboplatin and Gemcitabine) | 6 | |
| Surgical Assignment | STARTED | Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab) | 34 | |
| Surgical Assignment | STARTED | Arm VII (Surgery; Carboplatin and Gemcitabine) | 5 | |
| Surgical Assignment | STARTED | Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab) | 37 | |
| Surgical Assignment | Randomized - Yes Surgery | Arm I (no Surgery; Carboplatin and Paclitaxel) | 0 | |
| Surgical Assignment | Randomized - Yes Surgery | Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) | 0 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 participant flowAdverse events3,664
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 (no Surgery; Carboplatin and Paclitaxel) | 0 | 316 | |
| other | Allergy/Immunology - Other | Immune system disorders | Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) | 2 | 456 | |
| other | Allergy/Immunology - Other | Immune system disorders | Arm III (Surgery; Carboplatin and Paclitaxel) | 0 | 33 | |
| other | Allergy/Immunology - Other | Immune system disorders | Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab) | 1 | 165 | |
| other | Allergy/Immunology - Other | Immune system disorders | Arm V (no Surgery; Carboplatin and Gemcitabine) | 0 | 6 | |
| other | Allergy/Immunology - Other | Immune system disorders | Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab) | 0 | 34 | |
| other | Allergy/Immunology - Other | Immune system disorders | Arm VII (Surgery; Carboplatin and Gemcitabine) | 0 | 5 | |
| other | Allergy/Immunology - Other | Immune system disorders | Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab) | 0 | 37 | |
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Arm I (no Surgery; Carboplatin and Paclitaxel) | 76 | 316 | |
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) | 86 | 456 |
1 to 10 of 3,664Source ClinicalTrials.gov
See all 3,664 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (no Surgery; Carboplatin and Paclitaxel) | 253 | 316 |
| Total, all-cause mortality | Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) | 299 | 456 |
| Total, all-cause mortality | Arm III (Surgery; Carboplatin and Paclitaxel) | 28 | 33 |
| Total, all-cause mortality | Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab) | 56 | 165 |
| Total, all-cause mortality | Arm V (no Surgery; Carboplatin and Gemcitabine) | 4 | 6 |
| Total, all-cause mortality | Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab) | 14 | 34 |
| Total, all-cause mortality | Arm VII (Surgery; Carboplatin and Gemcitabine) | 4 | 5 |
| Total, all-cause mortality | Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab) | 21 | 37 |
| Total, other adverse events | Arm I (no Surgery; Carboplatin and Paclitaxel) | 304 | 316 |
| Total, other adverse events | Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) | 376 | 456 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers3
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.
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Read this trial from software.
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