Trial · NCT00937560
A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer
NCT00937560, Phase 2, Completed, Hoffmann-La Roche; results first posted 2015-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer. Trials, record NCT00937560. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00937560
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer
- NCT number
- NCT00937560
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 190 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Ovarian Cancer
- Interventions
- Bevacizumab, Paclitaxel, Carboplatin
- First posted
- 2009-07-13
- Last updated
- 2017-11-06
- Other registries' IDs
- eudract:2008-008336-85
- Results first posted
- 2015-02-24
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 | Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) | Progression-free survival was defined as the time from the first administration of any study treatment to the first disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first. |
| Secondary | Percentage of Participants With an Objective Response | Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) | An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), a CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions and a PR was defined as the disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the analysis according to RECIST only. Only participants with a Baseline ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal who had a ≥ 50% reduction of CA-125 from Baseline were included in the analysis according to CA-125 level. |
| Secondary | Duration of Response | Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) | Duration of response was defined as the interval between the date of the first documented response by RECIST to the date of first disease progression or death, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the analysis according to RECIST only. Only participants with a Baseline ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal who had a ≥ 50% reduction of CA-125 from Baseline were included in the analysis according to CA-125 level. |
| Secondary | Overall Survival at 1 Year and 2 Years | Baseline to Year 2 | Reported are the percentage of participants that were alive at 1 year and 2 years after enrolling in the study. |
| Secondary | Biological Progression-free Interval | Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) | Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for patients with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for patients with elevated CA-125 pre-treatment and initial normalisation of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per patient on 2 occasions at least 1 week apart (for patients with elevated CA-125 pre-treatment which never normalised). |
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 | Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) | Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel). | Months | MEDIAN |
| SECONDARY | Percentage of Participants With an Objective Response | Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) | Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel). | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response | Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) | Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel). | Months | MEDIAN |
| SECONDARY | Overall Survival at 1 Year and 2 Years | Baseline to Year 2 | Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel). | Percentage of participants | NUMBER |
| SECONDARY | Biological Progression-free Interval | Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) | Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel). | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Bevacizumab + Paclitaxel + Carboplatin | 23.7 | 90% Confidence Interval 19.9 to 26.4 | Months | |
| Percentage of Participants With an Objective Response | Bevacizumab + Paclitaxel + Carboplatin | RECIST only (N=91) | 84.6 | 95% Confidence Interval 75.5 to 91.3 | Percentage of participants |
| Percentage of Participants With an Objective Response | Bevacizumab + Paclitaxel + Carboplatin | CA-125 level only (N=101) | 97.0 | 95% Confidence Interval 91.6 to 99.4 | Percentage of participants |
| Percentage of Participants With an Objective Response | Bevacizumab + Paclitaxel + Carboplatin | RECIST and CA-125 level combined (N=126) | 92.1 | 95% Confidence Interval 85.9 to 96.1 | Percentage of participants |
| Duration of Response | Bevacizumab + Paclitaxel + Carboplatin | RECIST only (N=77) | 14.7 | 95% Confidence Interval 12.7 to 16.1 | Months |
| Duration of Response | Bevacizumab + Paclitaxel + Carboplatin | CA-125 level only (N=98) | 17.5 | 95% Confidence Interval 15.4 to 21.9 | Months |
| Duration of Response | Bevacizumab + Paclitaxel + Carboplatin | RECIST and CA-125 level combined (N=116) | 17.4 | 95% Confidence Interval 15.4 to 21.9 | Months |
| Overall Survival at 1 Year and 2 Years | Bevacizumab + Paclitaxel + Carboplatin | Year 1 | 97.7 | 95% Confidence Interval 95.4 to 99.9 | Percentage of participants |
| Overall Survival at 1 Year and 2 Years | Bevacizumab + Paclitaxel + Carboplatin | Year 2 | 92.1 | 95% Confidence Interval 88.0 to 96.2 | Percentage of participants |
| Biological Progression-free Interval | Bevacizumab + Paclitaxel + Carboplatin | NA | 95% Confidence Interval NA to NA | Months |
Source ClinicalTrials.gov
Participant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Treatment | STARTED | Bevacizumab + Paclitaxel + Carboplatin | 189 | |
| Initial Treatment | Received Treatment | Bevacizumab + Paclitaxel + Carboplatin | 189 | |
| Initial Treatment | COMPLETED | Bevacizumab + Paclitaxel + Carboplatin | 168 | |
| Initial Treatment | NOT COMPLETED | Bevacizumab + Paclitaxel + Carboplatin | 21 | |
| Maintenance Treatment | STARTED | Bevacizumab + Paclitaxel + Carboplatin | 168 | |
| Maintenance Treatment | COMPLETED | Bevacizumab + Paclitaxel + Carboplatin | 150 | |
| Maintenance Treatment | NOT COMPLETED | Bevacizumab + Paclitaxel + Carboplatin | 18 |
Source ClinicalTrials.gov
Adverse events97
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 | Neutropenia | Blood and lymphatic system disorders | Bevacizumab + Paclitaxel + Carboplatin | 153 | 189 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bevacizumab + Paclitaxel + Carboplatin | 85 | 189 | |
| other | Anaemia | Blood and lymphatic system disorders | Bevacizumab + Paclitaxel + Carboplatin | 111 | 189 | |
| other | Leukopenia | Blood and lymphatic system disorders | Bevacizumab + Paclitaxel + Carboplatin | 48 | 189 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Bevacizumab + Paclitaxel + Carboplatin | 14 | 189 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | Bevacizumab + Paclitaxel + Carboplatin | 11 | 189 | |
| other | Nausea | Gastrointestinal disorders | Bevacizumab + Paclitaxel + Carboplatin | 87 | 189 | |
| other | Diarrhoea | Gastrointestinal disorders | Bevacizumab + Paclitaxel + Carboplatin | 59 | 189 | |
| other | Constipation | Gastrointestinal disorders | Bevacizumab + Paclitaxel + Carboplatin | 64 | 189 | |
| other | Stomatitis | Gastrointestinal disorders | Bevacizumab + Paclitaxel + Carboplatin | 39 | 189 |
1 to 10 of 97Source ClinicalTrials.gov
See all 97 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab + Paclitaxel + Carboplatin | ||
| Total, other adverse events | Bevacizumab + Paclitaxel + Carboplatin | 186 | 189 |
| Total, serious adverse events | Bevacizumab + Paclitaxel + Carboplatin | 43 | 189 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24007819 | 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/NCT00937560
GET https://conductscience.org/api/trials/v1/NCT00937560/events?page=2