A Phase II Trial of 5-Fluorouracil Plus 776C85 in Patients With Advanced Resistant Colorectal Cancer

Study start date: April 1, 1998

Histologically or cytologically proven metastatic colorectal cancer Prior surgery required No prior treatment for metastatic disease Disease progression while on fluorouracil adjuvant therapy Bidimensionally measurable disease Age: Over 18 Performance status: SWOG 0-2 Hematopoietic: Platelet count at least 100,000/mm3, Absolute granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 3 times ULN (no greater than 5 times ULN if liver involvement) Renal: Creatinine clearance at least 50 mL/min Other: Must be able to swallow and retain oral medications No nutritional support by gastrostomy feeding tube or parenteral support No intractable vomiting or nausea Patients with history of prior malignancy must be currently disease free and off all therapy for that malignancy Not pregnant or nursing Fertile patients must use effective contraception Biologic therapy: No concurrent immunotherapy Chemotherapy; At least 3 weeks since prior chemotherapy and recovered; No concurrent flucytosine; No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: Prior adjuvant pelvic radiation or radiation to one area of recurrence allowed At least 4 weeks since prior radiotherapy and recovered Total area of bone marrow irradiation must not exceed 25% No concurrent radiotherapy Surgery: At least 2 weeks since prior surgery for colorectal cancer and recovered No prior resection of the stomach or small intestine Other: No other concurrent anticancer therapy