Phase II multicenter study of irinotecan and 5-fluorouracil/leucovorin as a front line therapy in advanced colorectal carcinoma

ABSTRACT

This multicenter phase II study was designed to assess the efficacy and tolerability of the combination of irinotecan with bolus 5-FU and calcium leucovorin [LV] as a front line therapy for advanced colorectal cancer [CRC]. Patients with histologically proven advanced CRC and at least one measurable lesion, with age range 18-75 years, with a performance status of <2, normal baseline biochemical values and no prior chemotherapy [apart from adjuvant] were selected. The treatment regimen was formed of weekly CPT-11 [125 mg/m2] i.v. infusion, 5-FU [500 mg/m2] bolus i.v. and LV [20 mg/m2] i.v. for four weeks [two weeks, followed by two weeks rest, this constitute one cycle]. Treatment continued till either complete remission or disease progression or failure