Colorectal Cancer RECHALLENGE

Sponsor
Sanofi
Study ID
NCT00988897
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OXALIPLATIN (SR96669) — DRUG
    Pharmaceutical form: Lyophilized powder for injection (50mg/vial or 100mg/vial) or aqueous solution (50mg/10mL or 100mg/20mL) Route of administration: IV
  • 5-FLUOROURACIL (5-FU) — DRUG
    Pharmaceutical form: vials of 5g/100mL (50mg/mL) Route of administration: IV
  • LEUCOVORIN (LV) — DRUG
    Pharmaceutical form: vials of 50mg/5mL or 500mg/50mL (10mg/mL) Route of administration: IV
  • BEVACIZUMAB — DRUG
    Pharmaceutical form: vials of 100mg/4mL or 400mg/16mL (25mg/mL) Route of administration: IV

Study Details

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.

Key Dates

First listed
Oct 2, 2009
Start date
Oct 31, 2009
Status verified
Dec 2009
Primary completion
May 31, 2012
Completion
May 31, 2012

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Patients will receive modified FOLFOX-6 regimen: * oxaliplatin 85mg/m2, day 1 (given as a 2-hour infusion) * LV 400mg/m2, day 1 (given as a 2-hour infusion simultaneous to oxaliplatin) * 5-FU given as a bolus IV 400mg/m2 dose on day 1 followed by 2400mg/m2 continuous infusion over 46 hours (day 1 and 2) A cycle is defined as 2 weeks. Patients will receive cycles of modified FOLFOX-6 regimen every 2 weeks up to a maximum of 8 cycles. Use of bevacizumab is at the discretion of the treating physician.

Primary Outcome Measure

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. ]

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