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- Title
Phase II trial of neocarzinostatin in patients with bladder and prostatic cancer: toxicity of a five-day iv bolus schedule.
- Authors
Natale, Ronald B.; Yagoda, Alan; Watson, Robin C.; Stover, Diane E.; Natale, R B; Yagoda, A; Watson, R C; Stover, D E
- Abstract
Neocarzinostatin (NCZ), a new antitumor antibiotic, was administered to 19 patients with bladder cancer, 16 patients with prostatic cancer, and 3 patients with hepatoma. All patients had objectively measurable metastatic lesions including 21 with palpable nodes or subcutaneous nodules, 10 with pulmonary nodules as demonstrated by chest x-ray, 4 with malignant hepatomegaly, and 3 with bidimensional pelvic masses as demonstrated by CT scanning. Sixty-five courses of NCZ were administered via an intravenous bolus daily for five days with dosages ranging from 1500 to 3000 U/m2. Immediate toxicity was not dose-limiting except for 1 episode of anaphylaxis and 1 of acute renal failure. Myelotoxicity was delayed, dose-dependent, noncumulative, and dose-limiting. Thrombocytopenia was prolonged or irreversible in 5 cases. The maximally tolerated dose was 2750 U/m2. One patient with NCZ-associated pulmonary fibrosis and 1 with biopsy-proven hepatitis are discussed in detail. Neocarzinostatin demonstrated minimal therapeutic activity (1 partial remission) in patients with bladder cancer. There was no response in patients with prostatic cancer or hepatoma.
- Subjects
BLADDER tumors; ANTINEOPLASTIC antibiotics; PROTEINS; RESEARCH; LEUCOPENIA; CLINICAL drug trials; HEMATOMA; CLINICAL trials; LIVER; RESEARCH methodology; METASTASIS; EVALUATION research; MEDICAL cooperation; TRANSITIONAL cell carcinoma; DRUG administration; COMPARATIVE studies; PULMONARY function tests; THROMBOCYTOPENIA; PROSTATE tumors
- Publication
Cancer (0008543X), 1980, Vol 45, Issue 11, p2836
- ISSN
0008-543X
- Publication type
journal article
- DOI
10.1002/1097-0142(19800601)45:11<2836::AID-CNCR2820451120>3.0.CO;2-7