A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.
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|ClinicalTrials.gov Identifier: NCT00700102|
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : July 30, 2015
Last Update Posted : July 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Chemotherapy Drug: Bevacizumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||820 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Active Comparator: Chemotherapy
Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
Experimental: Chemotherapy + Bevacizumab
Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
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.
Other Name: Avastin
- Overall Survival: Time From Randomization to Death From Any Cause [ Time Frame: within 6.5 years ]
- Overall Survival: Months From Time of First Line Therapy [ Time Frame: within approximately 9.6 years ]
- Participants With Progression Free Survival Event [ Time Frame: within 6.5 years ]
- Progression Free Survival: Time to Event [ Time Frame: within 6.5 years ]
- Response Rate: Percentage of Participants With Best Overall Response, Defined as Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST Criteria [ Time Frame: within 6.5 years ]
- Response Rate: Participants With Response Status Based on RECIST Criteria [ Time Frame: within 6.5 years ]Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700102
Show 301 Study Locations
|Study Director:||Clinical Trials||Hoffmann-La Roche|