Erlotinib in Combination With Cisplatin as Radiosensitizing Agents in Women Receiving Radiation Therapy for Locally Advanced Squamous Cell Carcinoma of the Cervix; A Phase I Trial
- Determine the maximum tolerated dose of erlotinib hydrochloride when administered with
cisplatin and pelvic radiotherapy in patients with stage IB-IVA squamous cell carcinoma
of the cervix.
- Determine the toxicity profile of this regimen.
OUTLINE: This is a multicenter, open-label, dose-escalation study of erlotinib
Patients receive oral erlotinib hydrochloride once daily on days 1-35 and cisplatin IV on
days 1, 8, 15, 22, and 29. Patients also undergo radiotherapy daily, 5 days a week, for
approximately 5 weeks concurrently with chemotherapy.
Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose proceeding that
at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed at 6 weeks.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of erlotinib hydrochloride
Levi S. Downs, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|