Status:
WITHDRAWN
Colorectal Cancer RECHALLENGE
Lead Sponsor:
Sanofi
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 chemot...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histologically proven adenocarcinoma of colon or rectum
- Measurable metastatic disease, either inoperable, or residual after surgical procedure
- No prior chemotherapy for metastatic disease
- For colon cancer: prior adjuvant chemotherapy with oxaliplatin that ended at least 12 months prior to enrollment.
- For rectal cancer: at least 12 months since prior use of oxaliplatin in neoadjuvant or adjuvant chemotherapy
- Adequate liver and kidney function:
- Total bilirubin inferior to 1.5 ULN
- Serum Creatinine inferior to 150 umol/L
- Creatinine clearance (ClCr) \> 30 mL/min
- ALT / AST inferior to 3 ULN
- Adequate hematological function
- Neutrophils \> or equal 1.5 x 109/L
- Platelets \> or equal 100 x 109/L
- Exclusion criteria:
- Metastatic disease presenting without prior adjuvant chemotherapy
- Metastatic disease presenting after non-oxaliplatin-containing adjuvant chemotherapy
- Peripheral sensory or motor neuropathy \> grade 1
- Eastern Cooperative Oncology Group (ECOG) Performance status \> 2
- Other active malignancy
- History of known allergy to oxaliplatin or other platinum compounds, to 5-FU, to Leucovorin or to any ingredients in the formulations or the containers
- Patients who are pregnant, or breast-feeding
- Patients with severe renal impairment (ClCr \< 30 mL/min)
- Pernicious anemia or other megaloblastic anemia with Vitamin B12 deficiency
- Patients with reproductive potential not implementing accepted and effective method of contraception (the definition of effective method of contraception will be based on the investigators' judgment)
- Participation in another clinical trial with any investigational drug within 30 days prior to study screening
- For patient who will receive Bevacizumab: Bevacizumab is contraindicated in patients with know hypersensitivity to any components of the product and to Chinese hamster ovary cell product or other recombinant human or humanized antibodies
- Presence of any symptoms suggesting brain metastasis
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00988897
Start Date
October 1 2009
End Date
May 1 2012
Last Update
December 23 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Laval, Canada