Weekly Docetaxel and Carboplatin in Patients With Recurrent Squamous Carcinoma of the Cervix: A Phase I/II Study

Date de début de l'étude : 1 novembre 2003

DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the uterine cervix * Advanced disease (stage IVB) * Persistent or recurrent disease * No available curative treatment options * Measurable disease by physical examination, chest x-ray, CT scan, or MRI PATIENT CHARACTERISTICS: Age * Over 18 Performance status * GOG 0-2 Life expectancy * More than 6 months Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 8 g/dL Hepatic * Bilirubin normal * SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal OR * Alkaline phosphatase ≤ 4 times ULN AND SGOT and SGPT normal Renal * Creatinine \< 1.5 times ULN Other * No other invasive malignancy within the past 5 years * No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * No peripheral neuropathy \> grade 1 * No other concurrent malignancy except curatively treated non-melanoma skin cancer * No other serious medical or psychiatric illness that would preclude giving informed consent or limit survival * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent biologic therapy Chemotherapy * No more than 2 prior chemotherapy regimens * One sensitizing chemotherapy regimen during radiotherapy AND 1 regimen for recurrent disease are considered 2 regimens * At least 4 weeks since prior chemotherapy * No prior docetaxel * No prior carboplatin * No other concurrent chemotherapy Endocrine therapy * At least 4 weeks since prior hormonal therapy Radiotherapy * See Chemotherapy * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * At least 3 weeks since prior major surgery