Phase II trial of piperazinedione (NSC 135758) in the treatment of advanced or recurrent carcinoma of the ovary. A Gynecologic Oncology Group study.
Thirty-eight patients with advanced or recurrent epithelial ovarian cancer no longer amenable to management with surgery, radiotherapy, or chemotherapy with known activity were given piperazinedione 9 mg/m2 intravenously every 3 weeks. Of the 31 patients evaluable for response, only one achieved a partial response of disease (3%), while there were no complete responses. Fourteen (45%) experienced progression of disease less than 1 month after starting therapy. Adverse effects consisted primarily of myelosuppression (81%), nausea and vomiting (32%), and azotemia (29%) with three patients (10%) having life-threatening thrombocytopenia. While adverse effects were tolerated, the drug at the dose and schedule tested has only minimal activity at best and should not be considered for further trials in epithelial ovarian cancer.
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D013921:Thrombocytopenia / Q000139:chemically induced; D014511:Uremia / Q000139:chemically induced
D000903:Antibiotics, Antineoplastic; D010879:Piperazines; C003905:3,6-bis(5-chloro-2-piperidyl)-2,5-piperazinedione