A Phase I Study of Paclitaxel and Cyclophosphamide in Recurrent Adenocarcinoma of the Ovary |
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Authors: | Eddie Reed MD Gisele Sarosy MD Elise Kohn MD Michaele Christian MD Charles J Link Jr MD Barry Goldspiel PharmD Patricia Davis RN OCN Joan Jacob RN Martha Maher RN |
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Institution: | Medical Ovarian Cancer Section, Clinical Pharmacology Branch, National Cancer Institute, Building 10, Room 12N226, Bethesda, Maryland, 20892 |
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Abstract: | We have conducted a disease specific phase I study of paclitaxel and cyclophosphamide in recurrent adenocarcinoma of the ovary. This was done to take advantage of the cellular and molecular synergism between paclitaxel and DNA-damaging agents, with the hope of avoiding paclitaxel–cisplatin toxicities. Paclitaxel was given as a 24-hr CIVI, after which cyclophosphamide was given as a 60-min infusion. Cycles of therapy were repeated every 3 weeks; and granulocyte colony-simulating factor (G-CSF) was given in a “flexible” dosing fashion. Starting doses were 170 mg/m2paclitaxel and 750 mg/m2cyclophosphamide. Dose-limiting toxicity (DLT) was seen at the doses of 250 mg/m2paclitaxel and 1250 mg/m2cyclophosphamide. DLT was cumulative thrombocytopenia. There were six nonhematologic grade 3 or 4 toxicities experienced in the study. Eleven of 20 evaluable patients (55%) have achieved an objective response (4 CCR;7 PR). Three of four CCRs were confirmed by negative findings at peritoneoscopy. The median number of prior therapies was 2 (range 1–4) and 17 individuals had platinum-refractory disease. We conclude that paclitaxel followed by cyclophosphamide is an active combination in recurrent ovarian cancer and that further study is needed to determine if this combination is truly better than paclitaxel alone. |
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