Colorectal Cancer RECHALLENGE
Phase 2
Withdrawn
- Conditions
- Colorectal Neoplasms
- Interventions
- Registration Number
- NCT00988897
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
* To demonstrate that re-challenge with an oxaliplatin based regimen (modified FOLFOX-6) will provide a clinical disease control rate (DCR) of at least 20% at the end of the chemotherapy.
Secondary Objective:
* To evaluate other measures of tumour's responses and safety.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 OXALIPLATIN (SR96669) Patients will receive modified FOLFOX-6 regimen: * oxaliplatin 85mg/m2, day 1 (given as a 2-hour infusion) * LV 400mg/m2, day 1 (given as a 2-hour infusion simultaneous to oxaliplatin) * 5-FU given as a bolus IV 400mg/m2 dose on day 1 followed by 2400mg/m2 continuous infusion over 46 hours (day 1 and 2) A cycle is defined as 2 weeks. Patients will receive cycles of modified FOLFOX-6 regimen every 2 weeks up to a maximum of 8 cycles. Use of bevacizumab is at the discretion of the treating physician. 1 LEUCOVORIN (LV) Patients will receive modified FOLFOX-6 regimen: * oxaliplatin 85mg/m2, day 1 (given as a 2-hour infusion) * LV 400mg/m2, day 1 (given as a 2-hour infusion simultaneous to oxaliplatin) * 5-FU given as a bolus IV 400mg/m2 dose on day 1 followed by 2400mg/m2 continuous infusion over 46 hours (day 1 and 2) A cycle is defined as 2 weeks. Patients will receive cycles of modified FOLFOX-6 regimen every 2 weeks up to a maximum of 8 cycles. Use of bevacizumab is at the discretion of the treating physician. 1 5-FLUOROURACIL (5-FU) Patients will receive modified FOLFOX-6 regimen: * oxaliplatin 85mg/m2, day 1 (given as a 2-hour infusion) * LV 400mg/m2, day 1 (given as a 2-hour infusion simultaneous to oxaliplatin) * 5-FU given as a bolus IV 400mg/m2 dose on day 1 followed by 2400mg/m2 continuous infusion over 46 hours (day 1 and 2) A cycle is defined as 2 weeks. Patients will receive cycles of modified FOLFOX-6 regimen every 2 weeks up to a maximum of 8 cycles. Use of bevacizumab is at the discretion of the treating physician. 1 BEVACIZUMAB Patients will receive modified FOLFOX-6 regimen: * oxaliplatin 85mg/m2, day 1 (given as a 2-hour infusion) * LV 400mg/m2, day 1 (given as a 2-hour infusion simultaneous to oxaliplatin) * 5-FU given as a bolus IV 400mg/m2 dose on day 1 followed by 2400mg/m2 continuous infusion over 46 hours (day 1 and 2) A cycle is defined as 2 weeks. Patients will receive cycles of modified FOLFOX-6 regimen every 2 weeks up to a maximum of 8 cycles. Use of bevacizumab is at the discretion of the treating physician.
- Primary Outcome Measures
Name Time Method Primary endpoint for the first thirteen patients according to the Simons Design: Clinical DCR (Disease Control Rate) at the end of stage I, based on Response Evaluation Criteria on Solid Tumors (RECIST) criteria. At the end of 8 cycles or end of treatment which occurs first.
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) evaluated at 10 weeks, 16 weeks and 40 weeks Duration of response evaluated at 10 weeks, 16 weeks and 40 weeks Adverse events At each visit, i.e. every two weeks Overall response rate of stage I and II evaluated at week 14
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇨🇦Laval, Canada