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- W4249331300 abstract "5153 Background: Topotecan is an active second-line agent for ovarian cancer but combinations with carboplatin have been limited by myeolsuppression. Weekly topotecan has been associated with less myelosuppression and moderate activity. We performed a phase I trial of weekly topotecan and carboplatin in potentially platinum sensitive ovarian and peritoneal carcinoma. Methods: Patients with evaluable potentially platinum sensitive ovarian or peritoneal carcinoma with PS 0–2, normal bone marrow, renal and hepatic function were eligible. Patients with a creatinine clearance of <50 cc/min by Jelliffe were excluded. Carboplatin at an AUC of 4 and in subsequent patients at an AUC of 5 with topotecan 2.0 mg/m2 was administered IV on day 1 each over 30 minutes. Topotecan at 2.0 mg/m2 was administered on days 8 and 15 provided the day of therapy ANC was ≥1,500/mcl and platelet count ≥100,000/mcl. Cycles were prescribed every 21 days. Dose escalation of topotecan was planned at 0.5 mg/m2 increments to a maximum of 4 mg/m2/week. Results: Thirteen patients were enrolled with 64 (median 5) every 21 day courses have been administered. With carboplatin at an AUC of 4, dose limiting toxicity was seen with topotecan at the starting dose of 2.0 mg/m2 and further escalation of topotecan was not possible. Since the dose limiting toxicity was neutropenia, the dose of carboplatin was elevated to an AUC of 5. This was tolerated with topotecan on day 1 and 8, but the day 15 dose was held on 43/64 (85%) of treatments due to inadequate neutrophil and/or platelet counts. Weekly topotecan on day 1 and 8 was well tolerated but in all but one patient, when day 15 topotecan was administered delays in subsequent therapy occurred. Responses have been seen in 7 of 10 evaluable patients. Conclusion: Carboplatin at an AUC of 5 in combination with topotecan at a dose of 2.0 mg/m2 on day 1and 8 is tolerable and active in potentially platinum sensitive ovarian or peritoneal carcinoma. A phase II study is planned. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration GlaxoSmithKline GlaxoSmithKline GlaxoSmithKline GlaxoSmithKline" @default.
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- W4249331300 date "2004-07-15" @default.
- W4249331300 modified "2023-09-25" @default.
- W4249331300 title "A phase I trial of weekly topotecan and carboplatin in potentially platinum sensitive ovarian and peritoneal carcinoma" @default.
- W4249331300 doi "https://doi.org/10.1200/jco.2004.22.90140.5153" @default.
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