Conditions: Metastatic Colorectal Cancer
Keywords: colorectal neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 768
Healthy volunteers: no

Brief summary:
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.

Detailed description:
On June 25, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181122. The DMC determined Study A6181122 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus FOLFIRI versus placebo plus FOLFIRI. No new safety findings were noted. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Patients receiving benefit on treatment as determined by the investigator may remain on study.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: 5 fluorouracil intervention 2: irinotecan intervention 3: levo- leucovorin intervention 4: sunitinib intervention 5: 5 fluorouracil intervention 6: irinotecan intervention 7: levo- leucovorin intervention 8: placebo
Intervention descriptions: intervention 1: 400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days intervention 2: 180mg/m2 iv day 1 every 14 days intervention 3: 200mg/m2 iv; day 1 every 14 days intervention 4: 37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period intervention 5: 400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days intervention 6: 180mg/m2 iv day 1 every 14 days intervention 7: 200mg/m2 iv; day 1 every 14 days intervention 8: 37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period

Protocol document: