Status:
COMPLETED
Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.
Lead Sponsor:
Sanofi
Conditions:
Metastases
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and placebo group. Mai...
Eligibility Criteria
Inclusion
- Main inclusion criteria :
- Histologically or cytologically-proven metastatic cancer of the colon or rectum.
- Metastatic disease not amenable to potentially curative treatment (eg: inoperable metastatic disease).
- Male or female aged \>18 years.
- WHO Performance Status (PS) : 0 or 1.
- Measurable disease.
- No prior chemotherapeutic regimen for metastatic disease.
- Disease-free interval from end of adjuvant therapy of at least 6 months (1 year if oxaliplatin was part of the adjuvant therapy).
- Prior radiotherapy is permitted if it was not administered to target lesions identified for this study - unless progression within the radiation portal is documented - and provided it has been completed at least 3 weeks before randomization.
- Signed written informed consent prior to study entry.
Exclusion
- Main exclusion criteria :
- Any condition or past medical history that contra-indicates treatment with oxaliplatin and 5-FU, as reported in approved labeling information.
- Received chemotherapeutic agents other than 5-FU, LV, Levamisole, irinotecan, capecitabine, oxaliplatin as part of adjuvant therapy.
- Peripheral neuropathy \>Grade 1.
- Concomitant treatments with drugs/ingredients reported to have a potential activity in preventing peripheral sensory neuropathy.
- Concurrent active cancer originating from a primary site other than colon or rectum.
- Presence of any symptom suggesting brain metastasis.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
879 Patients enrolled
Trial Details
Trial ID
NCT00305188
Start Date
December 1 2005
End Date
October 1 2009
Last Update
May 4 2016
Active Locations (13)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
3
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
4
Sanofi-Aventis Administrative Office
São Paulo, Brazil