Trial · NCT01239732
A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer
NCT01239732, Phase 3, Completed, Hoffmann-La Roche; results first posted 2016-06-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer. Trials, record NCT01239732. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01239732
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer
- NCT number
- NCT01239732
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,021 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Ovarian Cancer
- Interventions
- Paclitaxel, Bevacizumab, Carboplatin
- First posted
- 2010-11-11
- Last updated
- 2016-06-10
- Other registries' IDs
- eudract:2010-019525-34
- Results first posted
- 2016-06-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With at Least One Adverse Event (AE) | Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
| Secondary | Progression-Free Survival (PFS) | Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years | PFS was defined as the time between the date of first administration of any study treatment and the date of first documented protocol-defined disease progression (that is \[i.e.\], radiologically by Response Evaluation Criteria In Solid Tumors \[RECIST\], clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. Kaplan-Meier estimation was used for median time to PFS. |
| Secondary | Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0 | Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks (Q26W) after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years | Best overall response (BOR) according to RECIST Version 1.0 was categorized as: CR, PR, progressive disease (PD), stable disease (SD). CR: disappearance of all target lesions and non-target lesions. PR: \>=30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions. PD: Natural progression or deterioration of the malignancy under study (including new sites of metastasis). SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Participants with a BOR of CR and PR were defined as responders, while participants with a BOR of SD, PD, or unable to assess were defined as non-responders. |
| Secondary | Percentage of Participants Achieving an Overall Response by 50% Carcinoma Antigen 125 (CA-125) Response Criteria | 3 days prior to Day 1 of every cycle, then every 6 weeks (Q6W) during the first year, every 3 months (Q3M) in the second and third year, every 6 months (Q6M) in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years) | CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days. Overall response according to CA-125 was only evaluated for participants with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the upper limit of normal (ULN). |
| Secondary | Percentage of Participants Achieving an Overall Response by RECIST Version 1.0 and/or 50% CA-125 Response Criteria | RECIST: Day 1, at end of Cycles 3 and 6, then every 6 cycles, at bevacizumab cessation, Q26W after cessation; CA-125: 3 days before Day 1 of every cycle, then Q6W(1st year), Q3M(2nd-3rd year), Q6M(4th year); until data cutoff 07Dec2014, up to 4 years | Overall response was only evaluated for participants who were evaluable according to RECIST v1.0 with a measurable disease at baseline and/or according to CA-125 with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the ULN. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (\>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions). CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days. |
| Secondary | Duration of Objective Response (DOR) | Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years | DOR was defined as the time from the first documented response (CR or PR per RECIST v1.0), to the first documented protocol-defined disease progression (i.e., radiologically by RECIST, clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (\>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions). Disease progression: Natural progression or deterioration of the malignancy under study (including new sites of metastasis). |
| Secondary | Overall Survival (OS) | First administration of any study treatment until death or data cutoff 07 December 2014, up to 4 years | OS was defined as the time from the date of the first administration of any study treatment to the date of death, regardless of the cause of death. Participants without the event of death were censored at the last date in the study, defined as the latest date of the following: the date of first administration of study treatment, date of last study treatment, date of last visit, or date last known to be alive. Kaplan-Meier estimation was used for OS. |
| Secondary | Biological Progression-free Interval | 3 days prior to Day 1 of every cycle, then every 6 weeks during the first year, every 3 months in the second and third year, every 6 months in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years) | 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 participants 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 participants with elevated CA-125 pre-treatment and initial normalization 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 participant on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment which never normalized). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With at Least One Adverse Event (AE) | Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years) | Safety population | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years | Intent to treat population included all participants who received at least one dose of study medication. | months | MEDIAN |
| SECONDARY | Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0 | Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks (Q26W) after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years | ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving an Overall Response by 50% Carcinoma Antigen 125 (CA-125) Response Criteria | 3 days prior to Day 1 of every cycle, then every 6 weeks (Q6W) during the first year, every 3 months (Q3M) in the second and third year, every 6 months (Q6M) in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years) | ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving an Overall Response by RECIST Version 1.0 and/or 50% CA-125 Response Criteria | RECIST: Day 1, at end of Cycles 3 and 6, then every 6 cycles, at bevacizumab cessation, Q26W after cessation; CA-125: 3 days before Day 1 of every cycle, then Q6W(1st year), Q3M(2nd-3rd year), Q6M(4th year); until data cutoff 07Dec2014, up to 4 years | ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome. | percentage of participants | NUMBER |
| SECONDARY | Duration of Objective Response (DOR) | Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years | ITT population | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | First administration of any study treatment until death or data cutoff 07 December 2014, up to 4 years | ITT population | months | MEDIAN |
| SECONDARY | Biological Progression-free Interval | 3 days prior to Day 1 of every cycle, then every 6 weeks during the first year, every 3 months in the second and third year, every 6 months in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years) | Previous studies linking CA-125 levels with bevacizumab exposure as a potential secondary outcome measure for PFS did not produce any reliable information. Therefore, it was decided that data for this outcome measure should not be analyzed, as agreed with the study steering committee. |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With at Least One Adverse Event (AE) | Bevacizumab + Paclitaxel + Carboplatin | 97.8 | percentage of participants | ||
| Progression-Free Survival (PFS) | Bevacizumab + Paclitaxel + Carboplatin | 25.5 | 95% Confidence Interval 23.7 to 27.6 | months | |
| Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0 | Bevacizumab + Paclitaxel + Carboplatin | 72.7 | 95% Confidence Interval 68.2 to 76.9 | percentage of participants | |
| Percentage of Participants Achieving an Overall Response by 50% Carcinoma Antigen 125 (CA-125) Response Criteria | Bevacizumab + Paclitaxel + Carboplatin | 91.8 | 95% Confidence Interval 88.3 to 94.5 | percentage of participants | |
| Percentage of Participants Achieving an Overall Response by RECIST Version 1.0 and/or 50% CA-125 Response Criteria | Bevacizumab + Paclitaxel + Carboplatin | 82.4 | 95% Confidence Interval 79.0 to 85.4 | percentage of participants | |
| Duration of Objective Response (DOR) | Bevacizumab + Paclitaxel + Carboplatin | 18.2 | 95% Confidence Interval 16.6 to 19.6 | months | |
| Overall Survival (OS) | Bevacizumab + Paclitaxel + Carboplatin | NA | 95% Confidence Interval NA to NA | months |
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 + Paclitaxel + Carboplatin | 1,021 | |
| Overall Study | COMPLETED | Bevacizumab + Paclitaxel + Carboplatin | 0 | |
| Overall Study | NOT COMPLETED | Bevacizumab + Paclitaxel + Carboplatin | 1,021 |
Source ClinicalTrials.gov
Adverse events233
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 | 485 | 1,021 | |
| other | Anaemia | Blood and lymphatic system disorders | Bevacizumab + Paclitaxel + Carboplatin | 333 | 1,021 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bevacizumab + Paclitaxel + Carboplatin | 279 | 1,021 | |
| other | Leukopenia | Blood and lymphatic system disorders | Bevacizumab + Paclitaxel + Carboplatin | 109 | 1,021 | |
| other | Nausea | Gastrointestinal disorders | Bevacizumab + Paclitaxel + Carboplatin | 393 | 1,021 | |
| other | Diarrhoea | Gastrointestinal disorders | Bevacizumab + Paclitaxel + Carboplatin | 258 | 1,021 | |
| other | Constipation | Gastrointestinal disorders | Bevacizumab + Paclitaxel + Carboplatin | 255 | 1,021 | |
| other | Vomiting | Gastrointestinal disorders | Bevacizumab + Paclitaxel + Carboplatin | 230 | 1,021 | |
| other | Abdominal pain | Gastrointestinal disorders | Bevacizumab + Paclitaxel + Carboplatin | 221 | 1,021 | |
| other | Stomatitis | Gastrointestinal disorders | Bevacizumab + Paclitaxel + Carboplatin | 110 | 1,021 |
1 to 10 of 233Source ClinicalTrials.gov
See all 233 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 | 980 | 1,021 |
| Total, serious adverse events | Bevacizumab + Paclitaxel + Carboplatin | 285 | 1,021 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27749456 | 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/NCT01239732
GET https://conductscience.org/api/trials/v1/NCT01239732/events?page=2