A phase I trial of combination chemotherapy employing carboplatin, vinca alkaloids, with or without bleomycin in patients with advanced malignant tumors Journal Article


Authors: Bajorin, D.; Kelsen, D. P.
Article Title: A phase I trial of combination chemotherapy employing carboplatin, vinca alkaloids, with or without bleomycin in patients with advanced malignant tumors
Abstract: A Phase I trial of three carboplatin-based combination chemotherapy regimens was conducted. These included: carboplatin plus vindesine; carboplatin, vindesine, plus bleomycin; and, carboplatin plus vinblastine. Carboplatin was administered every 28 days as an intravenous bolus. The initial dose was 150 mg/m2 and doses were escalated by 50 mg/m2 in each successive group of patients. Vindesine was given at a dose of 3 mg/m2 weekly for 5 doses, then every other week thereafter. Bleomycin, 10 units/m2 IV bolus, was followed by 10 units/m2/day infusion for 4 days (3-7 and 31-35). Vinblastine was given at 5 mg/m2 every other week. Doses of vindesine, vinblastine, and bleomycin were not escalated. The maximum tolerated dose (MTD) of the carboplatin, vindesine bleomycin regimens was reached at a carboplatin dose of 250 mg/m2 and the MTD was influenced by the weekly vindesine in the initial 4 weeks of therapy. The MTD of the carboplatin and vinblastine regimen was reached at a carboplatin dose of 500 mg/m2. Dose-limiting toxicity of all three regimens was leukopenia. Although nonhematological toxicity of the carboplatin and vinblastine regimen included peripheral neuropathy and emesis, therapy was easily administered in an outpatient setting. The recommended Phase II dose of carboplatin is 450 mg/m2 in combination with vinblasrine at this dose and schedule for previously untreated patients. Twelve patients demonstrated major responses with the various regimens including 5 of 24 patients with adenocarcinoma of the upper gastrointestinal tract. © 1990 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted.
Keywords: adult; aged; major clinical study; advanced cancer; antineoplastic agents; neoplasms; carboplatin; leukopenia; antineoplastic combined chemotherapy protocols; vinblastine; bleomycin; vindesine; phase 1 clinical trial; organoplatinum compounds; intravenous drug administration; middle age; drug evaluation; human; male; female; priority journal; article; support, u.s. gov't, p.h.s.
Journal Title: Cancer Investigation
Volume: 8
Issue: 2
ISSN: 0735-7907
Publisher: Informa Healthcare  
Date Published: 1990-01-01
Start Page: 135
End Page: 141
Language: English
DOI: 10.3109/07357909009017558
PUBMED: 1698110
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 27 January 2020 -- Source: Scopus
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  1. Dean Bajorin
    657 Bajorin
  2. David P Kelsen
    537 Kelsen