SWOG clinical trial number
S0227
Phase III Randomized Trial of Cisplatin/Paclitaxel Versus Cisplatin/Gemcitabine in Recurrent, Persistent or Metastatic Carcinoma of the Cervix
Closed
Phase
Accrual
0%
Research committees
Gynecologic Cancer
Treatment
Cisplatin
Paclitaxel
Gemcitabine hydrochloride
Eligibility Criteria Expand/Collapse
Carcinoma of the cervix. Disease must be metastatic or must have recurred after prior complete response to primary treatment with surgery or irradiation, or must persist following surgery or radiation therapy. Measurable disease. At least 28 days must have elapsed since last radiation treatment and RT must not have included any measurable target lesion. No prior systemic therapy except for single agent chemotherapy used as radiosensitizer with external beam radiation therapy. Must have a chemotherapy-free interval of >6 months prior to registration. Must have recovered from all effects of prior surgery. Zubrod performance status 0-1. Must not have >= Grade 2 sensory or motor neuropathy. Adequate kidney function. No plans for concurrent antitumor treatment or palliative radiation. Must not be pregnant or nursing. No other prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.