Trial · NCT00886691
Bevacizumab With or Without Everolimus in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
NCT00886691, Phase 2, Completed, GOG Foundation; results first posted 2018-07-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bevacizumab With or Without Everolimus in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer. Trials, record NCT00886691. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00886691
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bevacizumab With or Without Everolimus in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
- NCT number
- NCT00886691
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 150 participants, actual
- Lead sponsor
- GOG Foundation
- Conditions
- Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
- Interventions
- Bevacizumab, Everolimus, Laboratory Biomarker Analysis, Placebo
- First posted
- 2009-04-23
- Last updated
- 2022-02-04
- Results first posted
- 2018-07-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | Duration of time from start of treatment to time of progression, approximately 4 years and 6 months. | The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as an 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 | Incidence of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) | All Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during treatment and up to 30 days after stopping the study treatment, approximately 4 years and 6 months. | Number of participants with a grade of 3 or higher during the treatment period. |
| Secondary | Characterize and Compare Progression-free Survival and Overall Survival in Patients With Measurable Disease (RECIST Criteria) and Patients With Detectable (Non-measurable) Disease | Continued until disease progression, assessed up to approximately 4 years and 6 months | Progression-free survival and overall survival broken down by measurable disease status |
| Secondary | The Proportion of Patients With Measurable Disease Who Have Objective Tumor Responses by Treatment. | Up to approximately 4 years and 6 months | Complete and Partial Tumor Response by RECIST 1.0 |
| Secondary | Percentage of Participants With at Least One Cancer Antigen 125 (CA-125) Response | Prior to each cycle of treatment. Then follow-up every three months for 2 years , then every 6 months for 3 years. Duration was approximately 4 years and 6 months. | Response as evaluated by CA-125 levels.A CA 125 test measures the amount of the protein CA 125 (cancer antigen 125) in blood.CA 125 is a tumor marker recommended for clinical use in the diagnosis and management of ovarian cancer. CA-125 responses were assessed with Rustin criteria. Initial values had to be 2x ULN (upper limit of normal) within 2 weeks of starting therapy to be considered evaluable.Patient were evaluated by using best overall response while receiving study therapy. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | Duration of time from start of treatment to time of progression, approximately 4 years and 6 months. | All intent to treat patients | months | MEDIAN |
| SECONDARY | Incidence of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) | All Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during treatment and up to 30 days after stopping the study treatment, approximately 4 years and 6 months. | All Intent to treat patients. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Characterize and Compare Progression-free Survival and Overall Survival in Patients With Measurable Disease (RECIST Criteria) and Patients With Detectable (Non-measurable) Disease | Continued until disease progression, assessed up to approximately 4 years and 6 months | All Intent to treat patients | Months | MEDIAN |
| SECONDARY | The Proportion of Patients With Measurable Disease Who Have Objective Tumor Responses by Treatment. | Up to approximately 4 years and 6 months | All measurable patients treated on Everolimus plus Bevicizumab and Placebo plus Bevacizumab. | percentage of participants responding | NUMBER |
| SECONDARY | Percentage of Participants With at Least One Cancer Antigen 125 (CA-125) Response | Prior to each cycle of treatment. Then follow-up every three months for 2 years , then every 6 months for 3 years. Duration was approximately 4 years and 6 months. | CA-125 evaluable patients | 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 | Everolimus (RAD001) Plus Bevacizumab | 5.9 | 95% Confidence Interval 4.11 to 7.69 | months | |
| Progression-free Survival | Placebo Plus Bevacizumab | 4.5 | 95% Confidence Interval 3.75 to 6.90 | months | |
| Incidence of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) | Everolimus (RAD001) Plus Bevacizumab | 43 | Participants | ||
| Incidence of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) | Placebo Plus Bevacizumab | 20 | Participants | ||
| Characterize and Compare Progression-free Survival and Overall Survival in Patients With Measurable Disease (RECIST Criteria) and Patients With Detectable (Non-measurable) Disease | PFS (Progression Free Survival) in Non-measurable Patients | 3.94 | 95% Confidence Interval 2.63 to 5.82 | Months | |
| Characterize and Compare Progression-free Survival and Overall Survival in Patients With Measurable Disease (RECIST Criteria) and Patients With Detectable (Non-measurable) Disease | PFS (Progression Free Survival) in Measurable Patients | 5.91 | 95% Confidence Interval 4.27 to 7.43 | Months | |
| Characterize and Compare Progression-free Survival and Overall Survival in Patients With Measurable Disease (RECIST Criteria) and Patients With Detectable (Non-measurable) Disease | OS (Overall Survival) in Non-measurable Patients | 11.10 | 95% Confidence Interval 7.59 to NA | Months | |
| Characterize and Compare Progression-free Survival and Overall Survival in Patients With Measurable Disease (RECIST Criteria) and Patients With Detectable (Non-measurable) Disease | OS (Overall Survival) in Measurable Patients | 16.92 | 95% Confidence Interval 12.16 to 18.43 | Months | |
| The Proportion of Patients With Measurable Disease Who Have Objective Tumor Responses by Treatment. | Everolimus (RAD001) Plus Bevacizumab | 22.2 | 95% Confidence Interval 12.7 to 34.5 | percentage of participants responding | |
| The Proportion of Patients With Measurable Disease Who Have Objective Tumor Responses by Treatment. | Placebo Plus Bevacizumab | 12.1 | 95% Confidence Interval 5.0 to 23.3 | percentage of participants responding |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Everolimus (RAD001) Plus Bevacizumab | 75 | |
| Overall Study | STARTED | Placebo Plus Bevacizumab | 75 | |
| Overall Study | COMPLETED | Everolimus (RAD001) Plus Bevacizumab | 75 | |
| Overall Study | COMPLETED | Placebo Plus Bevacizumab | 75 | |
| Overall Study | NOT COMPLETED | Everolimus (RAD001) Plus Bevacizumab | 0 | |
| Overall Study | NOT COMPLETED | Placebo Plus Bevacizumab | 0 |
Source ClinicalTrials.gov
Adverse events576
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 | Blood And Lymphatic System Disorders - Other | Blood and lymphatic system disorders | Everolimus (RAD001) Plus Bevacizumab | 1 | 75 | |
| other | Blood And Lymphatic System Disorders - Other | Blood and lymphatic system disorders | Placebo Plus Bevacizumab | 1 | 75 | |
| other | Anemia | Blood and lymphatic system disorders | Everolimus (RAD001) Plus Bevacizumab | 52 | 75 | |
| other | Anemia | Blood and lymphatic system disorders | Placebo Plus Bevacizumab | 26 | 75 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Everolimus (RAD001) Plus Bevacizumab | 1 | 75 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Placebo Plus Bevacizumab | 0 | 75 | |
| other | Supraventricular Tachycardia | Cardiac disorders | Everolimus (RAD001) Plus Bevacizumab | 1 | 75 | |
| other | Supraventricular Tachycardia | Cardiac disorders | Placebo Plus Bevacizumab | 0 | 75 | |
| other | Sinus Bradycardia | Cardiac disorders | Everolimus (RAD001) Plus Bevacizumab | 1 | 75 | |
| other | Sinus Bradycardia | Cardiac disorders | Placebo Plus Bevacizumab | 0 | 75 |
1 to 10 of 576Source ClinicalTrials.gov
See all 576 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Everolimus (RAD001) Plus Bevacizumab | ||
| Total, all-cause mortality | Placebo Plus Bevacizumab | ||
| Total, other adverse events | Everolimus (RAD001) Plus Bevacizumab | 73 | 75 |
| Total, other adverse events | Placebo Plus Bevacizumab | 72 | 75 |
| Total, serious adverse events | Everolimus (RAD001) Plus Bevacizumab | 35 | 75 |
| Total, serious adverse events | Placebo Plus Bevacizumab | 24 | 75 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37185961 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Everolimus (RAD001) Plus Bevacizumab vs Placebo Plus Bevacizumab: Incidence of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) | Trial comparisons |
| Everolimus (RAD001) Plus Bevacizumab vs Placebo Plus Bevacizumab: serious adverse events | 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/NCT00886691
GET https://conductscience.org/api/trials/v1/NCT00886691/events?page=2