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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Pharmaceutical form: Lyophilized powder for injection (50mg/vial or 100mg/vial) or aqueous solution (50mg/10mL or 100mg/20mL) Route of administration: IV
Pharmaceutical form: vials of 5g/100mL (50mg/mL) Route of administration: IV
Pharmaceutical form: vials of 50mg/5mL or 500mg/50mL (10mg/mL) Route of administration: IV
Sanofi-Aventis Administrative Office
Laval, Canada
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.
Time frame: At the end of 8 cycles or end of treatment which occurs first.
Progression-free survival (PFS)
Time frame: evaluated at 10 weeks, 16 weeks and 40 weeks
Duration of response
Time frame: evaluated at 10 weeks, 16 weeks and 40 weeks
Adverse events
Time frame: At each visit, i.e. every two weeks
Overall response rate of stage I and II
Time frame: evaluated at week 14
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Pharmaceutical form: vials of 100mg/4mL or 400mg/16mL (25mg/mL) Route of administration: IV