Oxaliplatin in Rectal Cancer
Phase 1
Terminated
- Conditions
- Rectal Neoplasms
- Registration Number
- NCT00259363
- Lead Sponsor
- Sanofi
- Brief Summary
* Phase I: To determine the maximum tolerated dose, and recommended dose of the proposed doses of oxaliplatin in this study
* Phase II: To determine the treatment efficacy according to response rates from phase I.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
- ECOG: 0-2
- Histological proved rectal adenocarcinoma
- No chemotherapy treatment on the previous 6 months before inclusion.
- No previous pelvic radiotherapy treatment
Exclusion Criteria
- Important Biological abnormality (renal, hepatic and/or hematological)
- Intestinal occlusion or subocclusion
- Peripheral neuropathy
- Pregnant or breast-feeding women. Potential child-bearing women with a positive pregnancy test.
- Participation in other trials on the previous 4 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Phase I : Maximum Tolerated Dose & Recommended Dose Days 1, 15, 29 Phase II : Response and resectability rate. 6 cycles in 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanofi-Aventis
🇪🇸Barcelona, Spain