Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer

Sponsor
Pfizer
Study ID
NCT00457691
Phase
PHASE3
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • 5 fluorouracil — DRUG
    400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
  • irinotecan — DRUG
    180mg/m2 iv day 1 every 14 days
  • levo- leucovorin — DRUG
    200mg/m2 iv; day 1 every 14 days
  • sunitinib — DRUG
    37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period
  • 5 fluorouracil — DRUG
    400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
  • irinotecan — DRUG
    180mg/m2 iv day 1 every 14 days
  • levo- leucovorin — DRUG
    200mg/m2 iv; day 1 every 14 days
  • placebo — DRUG
    37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period

Study Details

The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer.

Key Dates

Start date
Jun 30, 2007
Status verified
Mar 2015
Primary completion
Mar 31, 2010
Completion
Mar 31, 2010

Study Design

Enrollment
768 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Placebo Comparator: 2

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: First dose of study treatment up to 30 months ]

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