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Phase II trial of continuous drug infusions in advanced ovarian carcinoma: Acivicin versus vinblastine
Authors:Robert H. Earhart  Janardan D. Khandekar  David Faraggi  Roger A. Schinella  Thomas E. Davis
Affiliation:(1) Clinical Pharmacology and Efficacy Unit, The Upjohn Company, Kalamazoo, MI, USA;(2) Evanston Hospital, Northwestern University, Evanston, IL, USA;(3) Dana-Farber Cancer Institute, Boston, MA, USA;(4) New York University Medical Center, New York, NY, USA;(5) Stanford University, Palo Alto, CA, USA;(6) Clinical Pharmacology and Efficacy Unit, The Upjohn Company, 301 Henrietta Street, 49001 Kalamazoo, MI, USA
Abstract:Summary Sixty-six women with advanced ovarian carcinoma of coelomic epithelial origin were randomly assigned to one of two intravenous single-agent infusion treatment regimens, either acivicin (60 mg/m2/course, administered as a 72-hr infusion) or vinblastine (7.5 mg/m2/course, administered as a 120-hr infusion) every three weeks. All had progressive disease after one to three prior chemotherapeutic regimens. Of 62 patients who were evaluable for response, survival and toxicity, there was one partial response (2%) produced by vin-blastine. Median survival was 13 weeks on either treatment arm. Three patients (10%) on the acivicin arm experienced life-threatening myelosuppression. Severe toxicities resulting from this treatment included myelosuppression (26%), neurotoxicity (16%), mucositis (3%) and vomiting (6%). Vinblastine was associated with one lethal pneumonia and five cases of life-threatening myelosuppression (16%); severe toxicities included myelosuppression (58%), genitourinary toxicity (6%), infection (3%), and edema (3%). Neither regimen produces useful clinical results in patients who have relapsed after prior chemotherapy for ovarian carcinoma.This study was conducted by the Eastern Cooperative Oncology Group (Paul P. Carbone, chairman).
Keywords:phase II  ovarian carcinoma  acivicin  vinblastine
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