A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.
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| ClinicalTrials.gov Identifier: NCT00700102 |
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Recruitment Status :
Completed
First Posted : June 18, 2008
Results First Posted : July 30, 2015
Last Update Posted : July 30, 2015
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Colorectal Cancer |
| Interventions |
Drug: Chemotherapy Drug: Bevacizumab |
| Enrollment | 820 |
Participant Flow
| Recruitment Details | This study enrolled 820 patients at 220 sites located in 15 countries in Europe and Saudi Arabia. Study AIO KRK 0504 enrolled 261 patients, and 559 patients subsequently enrolled in Study ML18147 when the study was transferred to Hoffmann LaRoche (in 2008). |
| Pre-assignment Details |
| Arm/Group Title | Chemotherapy | Chemotherapy + Bevacizumab |
|---|---|---|
 Arm/Group Description |
Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal Chemotherapy: As prescribed |
Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal Chemotherapy: As prescribed Bevacizumab: Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle. |
| Period Title: Overall Study | ||
| Started | 411 | 409 |
| Intention to Treat | 410 | 409 |
| Received at Least One Dose | 407 | 403 |
| Completed | 9 | 14 |
| Not Completed | 402 | 395 |
| Reason Not Completed | ||
| Died | 394 | 385 |
| Lost to Follow-up | 8 | 10 |
Baseline Characteristics
| Arm/Group Title | Chemotherapy | Chemotherapy + Bevacizumab | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal Chemotherapy: As prescribed |
Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal Chemotherapy: As prescribed Bevacizumab: Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle. |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 411 | 409 | 820 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 411 participants | 409 participants | 820 participants | |
| 61.9 (9.55) | 62.1 (9.78) | 62.0 (9.66) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 411 participants | 409 participants | 820 participants | |
| Female |
152 37.0%
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142 34.7%
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294 35.9%
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| Male |
259 63.0%
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267 65.3%
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526 64.1%
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Outcome Measures
Adverse Events
Limitations and Caveats
Patients in the study who were randomized to receive bevacizumab could continue to receive bevacizumab following discontinuation of chemotherapy, thereby minimizing any potential bias introduced by differential follow-up time in the treatment arms.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
| Name/Title: | Medical Communications |
| Organization: | Hoffmann-La Roche |
| Phone: | 800 821-8590 |
| EMail: | genentech@druginfo.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00700102 |
| Other Study ID Numbers: |
ML18147 2006-004634-32 ( EudraCT Number ) |
| First Submitted: | June 17, 2008 |
| First Posted: | June 18, 2008 |
| Results First Submitted: | July 2, 2015 |
| Results First Posted: | July 30, 2015 |
| Last Update Posted: | July 30, 2015 |