Phase II Trial of Irinotecan in Patients With Metastatic Colorectal Carcinoma

摘要: PURPOSETo evaluate the objective tumor response rate and toxicities of patients with metastatic colorectal carcinoma treated irinotecan hydrochloride (CPT-11).PATIENTS AND METHODSA total 121 advanced carcinoma--90 prior fluorouracil (5-FU) exposure 31 chemotherapeutically naive patients--were enrolled between May 1993 June 1994. Patients were CPT-11 at 125 mg/m2 intravenously weekly for 4 weeks followed by a 2-week rest.RESULTSAmong 90 5-FU chemotherapy, 12 partial responses observed (response rate, 13.3%; 95% confidence interval [CI], 7.1% to 22.1%). Among chemotherapy-naive patients, eight had 25.8%; CI, 11.9% 44.6%). The median duration as measured from time initial treatment two groups was 7.7 months 7.6 months, respectively. major adverse reactions gastrointestinal hematologic. incidence grade 3 or diarrhea 36.4%, while o...