Trial · NCT01305213
Bevacizumab With or Without Fosbretabulin Tromethamine in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer
NCT01305213, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-07-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bevacizumab With or Without Fosbretabulin Tromethamine in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer. Trials, record NCT01305213. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01305213
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bevacizumab With or Without Fosbretabulin Tromethamine in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer
- NCT number
- NCT01305213
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 107 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
- Interventions
- Bevacizumab, Fosbretabulin Tromethamine, Laboratory Biomarker Analysis
- First posted
- 2011-02-28
- Last updated
- 2019-07-30
- Results first posted
- 2017-07-12
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) | For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21 day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, up to 5 years | 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. |
| Secondary | Incidence of Adverse Events (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 | Up to 5 years | Toxicities will be characterized by their frequency and severity. Differences in the level of toxicities by treatment regimen will be assessed by classifying them as severe or not severe and examining the relative proportion of severe toxicities. |
| Secondary | Measurable Disease by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria and Progression Free Survival (PFS) | Up to 5 years | Differences between measurable versus non-measurable disease status on PFS and OS will be examined with plots of survival curves, estimates of quartiles and hazard ratios. |
| Secondary | Tumor Response | for those patients whose disease can be evaluated by physical examination, response wa assessed prior to each 21 day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, up to 5 years | Complete and Partial Tumor Response by RECIST 1.0 |
| Secondary | Overall Survival (OS) | Up to 5 years | Differences between measurable versus non-measurable disease status on PFS and OS will be examined with plots of survival curves, estimates of quartiles and hazard ratios. |
| Secondary | Response by CA-125 | Up to 5 years | The effects of treatment on the proportion responding by CA125 will be examined. |
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) | For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21 day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, up to 5 years | All intent to treat patients | months | MEDIAN |
| SECONDARY | Incidence of Adverse Events (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 | Up to 5 years | All eligible and treated patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Measurable Disease by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria and Progression Free Survival (PFS) | Up to 5 years | months | MEDIAN | |
| SECONDARY | Tumor Response | for those patients whose disease can be evaluated by physical examination, response wa assessed prior to each 21 day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, up to 5 years | Patients with measurable disease | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Up to 5 years | months | MEDIAN | |
| SECONDARY | Response by CA-125 | Up to 5 years | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group46
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) | Arm I Bevacizumab | 4.83 | 95% Confidence Interval 4.14 to 6.24 | months | |
| Progression-free Survival (PFS) | Arm II Bevacizumab + Fosbretabulin | 7.23 | 95% Confidence Interval 4.30 to 10.51 | months | |
| Incidence of Adverse Events (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 | Arm I Bevacizumab | Thrombocytopenia | 0 | Participants | |
| Incidence of Adverse Events (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 | Arm II Bevacizumab + Fosbretabulin | Thrombocytopenia | 1 | Participants | |
| Incidence of Adverse Events (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 | Arm I Bevacizumab | Neutropenia | 3 | Participants | |
| Incidence of Adverse Events (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 | Arm II Bevacizumab + Fosbretabulin | Neutropenia | 1 | Participants | |
| Incidence of Adverse Events (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 | Arm I Bevacizumab | Other Investigations | 1 | Participants | |
| Incidence of Adverse Events (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 | Arm II Bevacizumab + Fosbretabulin | Other Investigations | 4 | Participants | |
| Incidence of Adverse Events (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 | Arm I Bevacizumab | Other Blood/Lymphatics | 0 | Participants | |
| Incidence of Adverse Events (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 | Arm II Bevacizumab + Fosbretabulin | Other Blood/Lymphatics | 1 | Participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I Bevacizumab | 53 | |
| Overall Study | STARTED | Arm II Bevacizumab + Fosbretabulin | 54 | |
| Overall Study | COMPLETED | Arm I Bevacizumab | 53 | |
| Overall Study | COMPLETED | Arm II Bevacizumab + Fosbretabulin | 54 | |
| Overall Study | NOT COMPLETED | Arm I Bevacizumab | 0 | |
| Overall Study | NOT COMPLETED | Arm II Bevacizumab + Fosbretabulin | 0 |
Source ClinicalTrials.gov
Adverse events434
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 | Leukocytosis | Blood and lymphatic system disorders | Arm I Bevacizumab | 0 | 53 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm II Bevacizumab + Fosbretabulin | 1 | 54 | |
| other | Anemia | Blood and lymphatic system disorders | Arm I Bevacizumab | 23 | 53 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II Bevacizumab + Fosbretabulin | 19 | 54 | |
| other | Atrial Fibrillation | Cardiac disorders | Arm I Bevacizumab | 0 | 53 | |
| other | Atrial Fibrillation | Cardiac disorders | Arm II Bevacizumab + Fosbretabulin | 2 | 54 | |
| other | Sinus Bradycardia | Cardiac disorders | Arm I Bevacizumab | 1 | 53 | |
| other | Sinus Bradycardia | Cardiac disorders | Arm II Bevacizumab + Fosbretabulin | 3 | 54 | |
| other | Palpitations | Cardiac disorders | Arm I Bevacizumab | 5 | 53 | |
| other | Palpitations | Cardiac disorders | Arm II Bevacizumab + Fosbretabulin | 4 | 54 |
1 to 10 of 434Source ClinicalTrials.gov
See all 434 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I Bevacizumab | ||
| Total, all-cause mortality | Arm II Bevacizumab + Fosbretabulin | ||
| Total, other adverse events | Arm I Bevacizumab | 53 | 53 |
| Total, other adverse events | Arm II Bevacizumab + Fosbretabulin | 52 | 54 |
| Total, serious adverse events | Arm I Bevacizumab | 9 | 53 |
| Total, serious adverse events | Arm II Bevacizumab + Fosbretabulin | 16 | 54 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27217446 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I Bevacizumab vs Arm II Bevacizumab + Fosbretabulin: 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/NCT01305213
GET https://conductscience.org/api/trials/v1/NCT01305213/results?page=2