TREE-2: Three Regimens of Eloxatin in Advanced Colorectal Cancer

Phase 2

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00399750
• Lead Sponsor: Sanofi

Brief Summary

A randomized, controlled, open-label multicenter trial to assess the safety and efficacy of 3 oxaliplatin-fluoropyrimidine containing regimens (mFOLFOX6; bFOL; XELOX) + Bevacizumab (TREE1 and TREE2) as first line therapy of advanced metastatic colorectal cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study Completion: 2005-06
• Study First Submitted: 2006-11-13
• Study First Submitted QC: 2006-11-14
• Study First Posted: 2006-11-15
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-14
• Last Update Posted: 2009-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and efficacy of three oxaliplatin-fluoropyrimidine regimens when combined with bevacizumab as therapy for previously untreated metastatic colorectal cancer (TREE 2)

Secondary Outcome Measures

Name	Time	Method
Time to tumor progression (TTP) (TREE1 and TREE2)
Actual treatment administration as characterized by median, mean, and range of doses given; dose modifications, omissions, and delays; and actual and relative dose intensity (TREE1 and TREE2)
Tumor response rate (overall and confirmed) based on application of the Response Evaluation Criteria in Solid Tumors (RECIST) (TREE1 and TREE2)
Time to treatment failure (TTF) (TREE1 and TREE2)
Median survival (TREE1 and TREE2)
STUDY DESIGN
A randomized, controlled, open-label multicenter trial to assess the safety & efficacy of 3 oxaliplatin-fluoropyrimidine containing regimens (mFOLFOX6; bFOL; XELOX) +Avastin (TREE1 & TREE2) as first line therapy of advanced metastatic colorectal cancer
The overall incidence of grade 3 and grade 4 adverse events during the first 12 weeks of treatment for each of the oxaliplatin-fluoropyrimidine regimens used without bevacizumab (TREE1)
Type, frequency, severity, timing, and relatedness of all adverse events during treatment and for 30 days following discontinuation of treatment for each of the oxaliplatin-fluoropyrimidine regimens when used with or without bevacizumab(TREE1 and TREE2)
Patients enrolled prior to the initiation of Amendment 3 (TREE1) will not be eligible to receive Avastin as a component of their treatment regimen.

Trial Locations

Locations (1)

Sanofi-Aventis; 🇺🇸 Bridgewater, New Jersey, United States