Status:
TERMINATED
Oxaliplatin in Rectal Cancer
Lead Sponsor:
Sanofi
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
- Main criteria are listed hereafter:
- ECOG: 0-2
- Histological proved rectal adenocarcinoma
- No chemotherapy treatment on the previous 6 months before inclusion.
- No previous pelvic radiotherapy treatment
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00259363
Start Date
October 1 2002
Last Update
December 7 2009
Active Locations (1)
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1
Sanofi-Aventis
Barcelona, Spain