Trial · NCT00407563
Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer
NCT00407563, Phase 2, Completed, Accelerated Community Oncology Research Network; results first posted 2012-04-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer. Trials, record NCT00407563. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00407563
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer
- NCT number
- NCT00407563
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Accelerated Community Oncology Research Network
- Conditions
- Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma
- Interventions
- Bevacizumab, Abraxane
- First posted
- 2006-12-05
- Last updated
- 2012-04-05
- Results first posted
- 2012-04-05
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6-month Progression-Free Rate | 6 months after initiation of study treatment | Progression-free rate is defined as the percentage of participants with no progression event at 6 months after starting study treatment. An event for this endpoint was defined as a progression-free survival event occurring earlier than six months, or discontinuation of treatment earlier than six months for any other reason. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. |
| Secondary | Best Overall Response | Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months. | Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR. |
| Secondary | Overall Survival | Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months. | |
| Secondary | Progression-free Survival (PFS) | PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first, assessed up to 30 months. | Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. |
| Secondary | Best Overall Response at Six Months | Assessed over 6 months of study treatment | The outcome measure assessed the percentage of participants who had achieved either a Partial or Complete Response over 6 months of treatment. Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR. |
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 | 6-month Progression-Free Rate | 6 months after initiation of study treatment | percentage of patients | NUMBER | |
| SECONDARY | Best Overall Response | Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months. | Participants | NUMBER | |
| SECONDARY | Overall Survival | Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months. | Participants who had not experienced death during or after stopping treatment were censored in the analysis. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first, assessed up to 30 months. | Participants who had not experienced either disease progression or death during or after stopping treatment were censored in the analysis. | Months | MEDIAN |
| SECONDARY | Best Overall Response at Six Months | Assessed over 6 months of study treatment | The 2 tailed, 95% confidence interval of the estimated response rate was calculated using the normal approximation to the binomial distribution. | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 6-month Progression-Free Rate | Bevacizumab and Abraxane | 62.5 | 95% Confidence Interval 47.8 to 77.2 | percentage of patients | |
| Best Overall Response | Bevacizumab and Abraxane | Complete response | 4 | Participants | |
| Best Overall Response | Bevacizumab and Abraxane | Partial response | 20 | Participants | |
| Best Overall Response | Bevacizumab and Abraxane | Stable disease | 14 | Participants | |
| Best Overall Response | Bevacizumab and Abraxane | Progressive disease | 8 | Participants | |
| Best Overall Response | Bevacizumab and Abraxane | Not evaluable | 2 | Participants | |
| Overall Survival | Bevacizumab and Abraxane | 17.15 | 95% Confidence Interval 13.57 to 23.82 | Months | |
| Progression-free Survival (PFS) | Bevacizumab and Abraxane | 8.08 | 95% Confidence Interval 5.78 to 10.15 | Months | |
| Best Overall Response at Six Months | Bevacizumab and Abraxane | 50 | 95% Confidence Interval 34.8 to 65.1 | percentage of patients |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bevacizumab and Abraxane | 48 | |
| Overall Study | COMPLETED | Bevacizumab and Abraxane | 47 | |
| Overall Study | NOT COMPLETED | Bevacizumab and Abraxane | 1 |
Source ClinicalTrials.gov
Adverse events238
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 | Anemia | Blood and lymphatic system disorders | Bevacizumab and Abraxane | 10 | 48 | |
| other | Leukopenia | Blood and lymphatic system disorders | Bevacizumab and Abraxane | 2 | 48 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Bevacizumab and Abraxane | 1 | 48 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Bevacizumab and Abraxane | 4 | 48 | |
| other | Neutropenia | Blood and lymphatic system disorders | Bevacizumab and Abraxane | 14 | 48 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bevacizumab and Abraxane | 1 | 48 | |
| other | Palpitations | Cardiac disorders | Bevacizumab and Abraxane | 1 | 48 | |
| other | External ear pain | Ear and labyrinth disorders | Bevacizumab and Abraxane | 1 | 48 | |
| other | Tinnitus | Ear and labyrinth disorders | Bevacizumab and Abraxane | 1 | 48 | |
| other | Blepharitis | Eye disorders | Bevacizumab and Abraxane | 1 | 48 |
1 to 10 of 238Source ClinicalTrials.gov
See all 238 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab and Abraxane | ||
| Total, other adverse events | Bevacizumab and Abraxane | 47 | 48 |
| Total, serious adverse events | Bevacizumab and Abraxane | 13 | 48 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22960352 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
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/NCT00407563
GET https://conductscience.org/api/trials/v1/NCT00407563/events?page=2