Phase i clinical trial of weekly and daily treatment with camptothecin (NSC-100880) : correlation with preclinical studies

Muggia, F.M.; Creaven, P.J.; Hansen, H.H.; Cohen, M.H.; Selawry, O.S.

Cancer ChemoTherapy Reports 56(4): 515-521

1972


ISSN/ISBN: 0069-0112
PMID: 5081595
Document Number: 5616
Tolerance to weekly and daily treatment with camptothecin was evaluated in patients with cancer. Fifteen patients were treated at four weekly dose levels ranging from 20 to 67 mg/m2. Reversible leukopenia was the major dose-limiting toxic effect. Five-day loading courses were begun at total doses of 1.5 mg/m2 per course because increased sensitivity to daily administration had been noted in animal studies. Leukopenia was more prolonged after daily treatment than after weekly treatment and occurred in four of six patients receiving a total dose of 100 mg/m2. Tolerance to 5-day courses was an unexpected result. Also unpredicted by preclinical studies was man's susceptibility to cystitis with either schedule of treatment. Since the purpose of this phase I trial was to establish toxicity parameters, therapeutic response was not evaluable in all patients; however, two of ten patients in whom response could be evaluated had objective responses after weekly courses of treatment. No clinical benefit was observed in eight patients with measurable disease who were treated with the 5-day courses at dose levels associated with toxicity.

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Phase i clinical trial of weekly and daily treatment with camptothecin (NSC-100880): correlation with preclinical studies