A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.
This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Overall Survival: Time From Randomization to Death From Any Cause [ Time Frame: within 6.5 years ] [ Designated as safety issue: No ]
- Overall Survival: Months From Time of First Line Therapy [ Time Frame: within approximately 9.6 years ] [ Designated as safety issue: No ]
- Participants With Progression Free Survival Event [ Time Frame: within 6.5 years ] [ Designated as safety issue: No ]
- Progression Free Survival: Time to Event [ Time Frame: within 6.5 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Response Rate: Participants With Response Status Based on RECIST Criteria [ Time Frame: within 6.5 years ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2006|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
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
As prescribedDrug: 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.
Other Name: Avastin
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700102
Show 301 Study Locations
|Study Director:||Clinical Trials||Hoffmann-La Roche|