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.
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.
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
180mg/m2 iv day 1 every 14 days
200mg/m2 iv; day 1 every 14 days
37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
180mg/m2 iv day 1 every 14 days
200mg/m2 iv; day 1 every 14 days
37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period
La Plata, Buenos Aires, Argentina
Santa Fe, Santa Fe Province, Argentina