A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.
Tracking Information | |||||
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First Received Date ICMJE | June 17, 2008 | ||||
Last Updated Date | September 19, 2012 | ||||
Start Date ICMJE | November 2005 | ||||
Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Overall survival (time from randomization to death of any cause) [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ] | ||||
Change History | Complete list of historical versions of study NCT00700102 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer. | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | This study will evaluate the efficacy and safety of adding Avastin (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 Avastin. Patients will be randomized to one of 2 chemotherapy strata. Those in stratum 1 will receive chemotherapy (AIO-IRI, FOLFIRI, CAPIRI or XELIRI) alone, or in combination with Avastin (5mg/kg iv on days 1 and 14 of each 4 week cycle or 7.5mg/kg on days 1 and 22 of each 6 week cycle) and those in stratum 2 will receive chemotherapy (FUFOX, FOLFOX, CAPOX or XELOX) alone, or in combination with Avastin (5mg/kg on days 1 and 14 of each 4 week cycle or 7.5mg/kg on days 1 and 22 of each 6 week cycle). The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Colorectal Cancer | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Enrollment ICMJE | 821 | ||||
Estimated Completion Date | June 2013 | ||||
Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Netherlands, Norway, Portugal, Saudi Arabia, Spain, Sweden, Switzerland | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00700102 | ||||
Other Study ID Numbers ICMJE | ML18147 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Hoffmann-La Roche | ||||
Study Sponsor ICMJE | Hoffmann-La Roche | ||||
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Investigators ICMJE |
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Information Provided By | Hoffmann-La Roche | ||||
Verification Date | September 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |