Phase I trial of sulindac plus 5-fluorouracil and levamisole: potential adjuvant therapy for colon carcinoma.
摘要:
Epidemiological studies indicate that may reduce incidence and mortality. Moreover, has been shown to attenuate the growth and progression of in an experimental model of and in patients with . To determine whether (300 mg/day) would increase toxicity associated with (5-FU) and levamisole, 15 patients with advanced were treated. Median treatment duration was 3 (range, 0.6-6.0) months, and median age was 56 years (33% >/= 60 years). All patients had failed prior 5-FU-based therapy, had , and were evaluable for toxicity. Grade III/IV occurred in four patients; three patients had received prior pelvic irradiation resulting in a predisposition to . Two patients developed grade III , and occult gastrointestinal bleeding was suspected in one. No other grade II or greater gastrointestinal or other nonhematological toxicity occurred. One patient had a partial response, 3 patients had disease stabilization, and 10 patients progressed on study. Our results indicate that does not significantly increase short-term toxicity associated with 5-FU and levamisole. To determine whether increases the efficacy of adjuvant chemotherapy, we propose a phase III randomized trial in patients with lymph node-positive .
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DOI:
10.1093/carcin/17.1.171
被引量:
年份:
1996
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