GOG 169:CISPLATIN VS CISPLATIN + PACLITAXEL IN SQUAMOUS CELL CARCINOM

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For patients with advanced, persistent or recurrent squamous cell carcinoma of the cervix no longer amenable to surgical resection or radiation therapy, the prognosis is bleak. The need for effective chemotherapy in this clinical setting is well-organized, and optimal treatment has yet to be defined. For a number of years, cisplatin has been considered the most active drug against cervical cancer with initial response rates as high as 50%. The GOG conducted a study of cisplatin at three dose schedules to see if improved results could be achieved through increased dose intensity. Although the response rate increased from 21% to 31% with an increase in dose from 50 mg/m2 to 100 mg/m2 every three weeks, there was no associated improvement in the complete response rate, progression-free interval, or survival. The impact of single-agent cisplatin chemotherapy on overall survival is debatable. Paclitaxel is a diterpenoid compound extracted from the bark of the Pacific yew and its cytotoxicity is believed to be exerted via stabilization of tubulin polymer bundles, thus interfering with microtubular assembly and cell replication. It has demonstrated broad activity against a number of solid tumors, including cancers of the ovary, breast and endometrium. The GOG reported a 17% response rate for Paclitaxel against advanced squamous cell carcinoma of the cervix. The combination of cisplatin and Paclitaxel has been effectively used against a number of malignancies and is presently undergoing investigation against various squamous cell cancers, including cervical cancer. The present study will determine if the combination of cisplatin plus Paclitaxel improves the response rate, progression-free interval, and/or survival in advanced squamous cervical cancer compared to treatment with cisplatin alone. Furthermore, in a clinical setting where standard treatment may be viewed as palliative in nature, the study will assess differences in the two arms with respect to toxicity and/or quality of life.