drugset / Trial / NCT00510250

A Phase I/II Study of Cisplatin and Radiation in Combination With Sorafenib in Cervical Cancer

NCT00510250

Phase 1/2 Completed 13 enrolled University Health Network, Toronto Bayer · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This will be a multi-institution, single-arm, open-label, phase I/II trial. Eligible patients will have pathologically-proven T1b-3b, N0/1, M0 epithelial carcinoma of the cervix. We hypothesize that sorafenib in combination with chemotherapy and radiotherapy may have anti-tumor activity in patients with cervical cancer. Sorafenib has not previously been combined with conventional RT-CT to treat cervix cancer.

Timeline

Start
2007-06
Primary completion
2010-09
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Sorafenib Small molecule 200 mg Oral
Background Cisplatin Other / unclassified 40 mg/m2 Intravenous

Indications