Trial · NCT01181609
A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum
NCT01181609, Phase 2, Completed, Hoffmann-La Roche; results first posted 2014-07-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum. Trials, record NCT01181609. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01181609
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum
- NCT number
- NCT01181609
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Colorectal Cancer
- Interventions
- bevacizumab [Avastin]
- First posted
- 2010-08-13
- Last updated
- 2014-07-28
- Results first posted
- 2014-07-28
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 Achieving Overall Disease Control (ODC) | Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up) | ODC was defined as the percentage of participants with measurable disease at baseline who on assessment achieved complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. CR and PR were confirmed no less than 4 weeks after the criteria for response were met. |
| Secondary | Percentage of Participants Achieving a Best Overall Response of CR or PR | Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) | Percentage of participants achieving CR or PR as defined by RECIST criteria. CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. CR and PR were confirmed no less than 4 weeks after the criteria for response were met. |
| Secondary | Progression-Free Survival (PFS) - Percentage of Participants With an Event | Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) | PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST. |
| Secondary | PFS - Time to Event | Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) | PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST. Median PFS was estimed using the Kaplan-Meier method. |
| Secondary | Duration of Response | Baseline, every cycle until progression or death (Maximum of 52.5 months follow-up) | Duration of response was defined as the time in months from the day of CR or PR was first noted to the day of progression of disease, death or last follow-up. Median duraiton of response is estimated sing the Kaplan-Meier method. |
| Secondary | Duration of Overall Disease Control | Baseline, every cycle until progression or death. (Maximum of 52.5 months follow-up) | ODC duration was defined as the time in months, from when measurement criteria were first met for CR, PR, or SD (whichever status was recorded first) until the first date when progressive disease or the death from any cause was documented. Data were censored for participants who were lost to follow-up, discontinued prematurely without progression/death, or who reached the end of study without progression. Median ODC was estimated using the Kaplan-Meier method. |
| Secondary | Overall Survival (OS) - Percentage of Participants With an Event | Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) | Overall survival was defined as the time from start of study treatment to death from any cause. |
| Secondary | OS - Time to Event | Baseline, every cycle to progression or death. (Maximum of 52.5 months follow-up) | OS was defined as the time from start of study treatment to death from any cause. Median OS was estimated using the Kaplan-Meier method. |
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 Achieving Overall Disease Control (ODC) | Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up) | ITT population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Best Overall Response of CR or PR | Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) | ITT population | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) - Percentage of Participants With an Event | Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) | ITT | percentage of participants | NUMBER |
| SECONDARY | PFS - Time to Event | Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) | ITT population | months | MEDIAN |
| SECONDARY | Duration of Response | Baseline, every cycle until progression or death (Maximum of 52.5 months follow-up) | ITT population; only participants with a response (CR or PR) were included in the analysis. | months | MEDIAN |
| SECONDARY | Duration of Overall Disease Control | Baseline, every cycle until progression or death. (Maximum of 52.5 months follow-up) | ITT population; only participants with an ODC response (CR, PR, or SD) were included in the analysis. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) - Percentage of Participants With an Event | Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) | ITT population | percentage of participants | NUMBER |
| SECONDARY | OS - Time to Event | Baseline, every cycle to progression or death. (Maximum of 52.5 months follow-up) | ITT population | months | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Overall Disease Control (ODC) | Bevacizumab + Chemotherapy | 87 | 95% Confidence Interval 77 to 97 | percentage of participants | |
| Percentage of Participants Achieving a Best Overall Response of CR or PR | Bevacizumab + Chemotherapy | 32 | 95% Confidence Interval 19 to 46 | percentage of participants | |
| Progression-Free Survival (PFS) - Percentage of Participants With an Event | Bevacizumab + Chemotherapy | 98 | percentage of participants | ||
| PFS - Time to Event | Bevacizumab + Chemotherapy | 6.5 | 95% Confidence Interval 5.8 to 7.8 | months | |
| Duration of Response | Bevacizumab + Chemotherapy | 6 | 95% Confidence Interval 4.8 to 7.5 | months | |
| Duration of Overall Disease Control | Bevacizumab + Chemotherapy | 6.7 | 95% Confidence Interval 5.2 to 7.1 | months | |
| Overall Survival (OS) - Percentage of Participants With an Event | Bevacizumab + Chemotherapy | 93.0 | percentage of participants | ||
| OS - Time to Event | Bevacizumab + Chemotherapy | 19.3 | 95% Confidence Interval 14,2 | 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 + Chemotherapy | 54 | |
| Overall Study | COMPLETED | Bevacizumab + Chemotherapy | 1 | |
| Overall Study | NOT COMPLETED | Bevacizumab + Chemotherapy | 53 |
Source ClinicalTrials.gov
Adverse events60
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 | Nausea | Gastrointestinal disorders | Bevacizumab + Chemotherapy | 35 | 53 | |
| other | Diarrhea | Gastrointestinal disorders | Bevacizumab + Chemotherapy | 32 | 53 | |
| other | Vomiting | Gastrointestinal disorders | Bevacizumab + Chemotherapy | 25 | 53 | |
| other | Abdominal pain | Gastrointestinal disorders | Bevacizumab + Chemotherapy | 13 | 53 | |
| other | Constipation | Gastrointestinal disorders | Bevacizumab + Chemotherapy | 12 | 53 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Bevacizumab + Chemotherapy | 8 | 53 | |
| other | Aphthous stomatitis | Gastrointestinal disorders | Bevacizumab + Chemotherapy | 5 | 53 | |
| other | Dyspepsia | Gastrointestinal disorders | Bevacizumab + Chemotherapy | 5 | 53 | |
| other | Toothache | Gastrointestinal disorders | Bevacizumab + Chemotherapy | 4 | 53 | |
| other | Haemorrhoids | Gastrointestinal disorders | Bevacizumab + Chemotherapy | 3 | 53 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab + Chemotherapy | ||
| Total, other adverse events | Bevacizumab + Chemotherapy | 52 | 53 |
| Total, serious adverse events | Bevacizumab + Chemotherapy | 9 | 53 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01181609
GET https://conductscience.org/api/trials/v1/NCT01181609/events?page=2