CLINICAL TRIAL: OXALIPLATIN IN COMBINATION WITH PACLITAXEL IN PATIENTS WITH CERV

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The aim of this phase I-II study is to determine the response rates and toxicities and recovery for patients with locally recurrent or metastatic cervical cancer. The rationale of the study is that there has been no improvement in survival in patients with metastatic (outside the pelvis) disease with chemotherapy/radiotherapy. Cisplatin has been the most active agent but has shown no improvement in clinical outcome. Cisplatinum/paclitaxel improves the response rate but not survival. The investigators will now try oxaliplatin, which has been shown to be active in some cisplatinum-resistant tumors. Also, there is no significant renal toxicity with oxaliplatin, and there has been a high incidence of renal involvement in this cohort. Endpoints of the study are measurable and non-measurable disease; complete response, partial response, etc; toxicity and recovery.