First-line Irinotecan Research Articles

Cetuximab plus FOLFOX for colorectal cancer (EXPLORE): Preliminary safety analysis of a randomized phase III trial

3531 Background: The EXPLORE study is a randomized phase III study comparing cetuximab (Erbitux) plus FOLFOX4 (5-FU, leucovorin, oxaliplatin), to FOLFOX4 in 2nd-line metastatic, EGFR-positive colorectal cancer (CRC) patients (pts). Since this study is the first experience combining cetuximab with FOLFOX4, an early safety assessment was performed. Methods: The first stage of this randomized phase III trial restricted accrual to 40 pts at 10 centers to obtain an early assessment of safety. Pts with metastatic EGFR-positive CRC who had progressed on prior first-line irinotecan therapy with an ECOG performance status <2 were randomized to either Arm A (cetuximab 400 mg/m2 initial dose followed by 250 mg/m2 weekly dose and FOLFOX4 d1,d2 q 2 weeks) or to Arm B (FOLFOX4 q 2 weeks). A pooled analysis of safety is presented. Results: Forty patients were randomized from March to November, 2003. They included 20 women and 20 men with a mean age of 61 years. Two patients did not receive study therapy and are excluded from the analysis. A total of 178 cycles were administered to the 38 pts with a median of 3 cycles per pt (range 1–15). There have been 4 disease-related deaths and one severe non-fatal hypersensitivity reaction (HSR). A summary table of adverse events associated with chemotherapy and cetuximab is below. The incidence and severity of these events appear comparable to previous reports of cetuximab with chemotherapy or of FOLFOX4. Conclusions: In this pooled analysis the characteristic toxicities of cetuximab and FOLFOX4 do not appear to be increased. The study is continuing to accrue to its target of 1100 patients. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb Bristol-Myers Squibb Roche Bristol-Myers Squibb

Multicenter phase II trial of first-line irinotecan (CPT-11) and gemcitabine (GMB) in patients with unresectable pancreatic cancer

Multicenter phase II trial of first-line irinotecan (CPT-11) and gemcitabine (GMB) in patients with unresectable pancreatic cancer