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Annals of Oncology 7:1077-1079, 1996
© 1996 European Society for Medical Oncology

other

A phase I study of bi-weekly paclitaxel/cisplatin as initial therapy for advanced ovarian cancer

A study of the National Cancer Institute of Canada Clinical Trials Group

K. Swenerton1, P. Hoskins1, G. Stuart2, G. Batist3, J. Pike1, N. Onetto4, B. Fisher5 and E. Eisenhauer5,

1BC Cancer Agency Vancouver, Canada
2Tom Baker Cancer Centre Calgary, Canada
3McGill Department of Oncology Montreal, Canada
4Bristol-Myers Squibb, Pharmaceutical Research Institute Wallingford, CT, USA
5New Drug Program, National Cancer Institute of Canada Clinical Trials Group Kingston, Ontario, Canada

Correspondence to: E. Eisenhauer, MD Director of the Investigational New Drug Program National Cancer Institute of Canada Clinical Trials Group 82–84 Barrie St. Kingston, Ontario, Canada K7L 3N6

PURPOSE:: Given the potential for improved outcomes, a phase I trial was initiated to develop a paclitaxel/cisplatin regimen that could be delivered every two weeks to women with newly diagnosed advanced ovarian cancer.

PATIENTS AND METHODS:: From 1992 to 1994, 29 (28 eligible) patients were enrolled in a dose-seeking trial. All received 60 mg/m2 of cisplatin preceded by paclitaxel infused over three hours. The paclitaxel dose was excalated from an initial level of 90 mg/m2 by 10 mg/m2 increments in successive cohorts of patients.

RESULTS:: At 120 mg/m2 of paclitaxel, the dose-limiting toxicity was granulocytopenia which prevented retreatment on time. The recommended dose level was therefore paclitaxel 110 mg/m2 infused over three hours with cisplatin 60 mg/m2, repeated bi-weekly for eight cycles.

CONCLUSION:: This bi-weekly schedule of paclitaxel/cisplatin provides no advantage in terms of dose-intensity nor total dose of paclitaxel in comparison to more common regimens given tri-weekly.

cisplatin, ovarian cancer, paclitaxel, phase I study


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