Cervical Cancer Clinical Trial
Official title:
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
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways
to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib and
cisplatin may make tumor cells more sensitive to radiation therapy. Giving erlotinib together
with cisplatin and radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when
given together with cisplatin and radiation therapy in treating patients with stage IB, stage
II, stage III, or stage IVA cervical cancer.
OBJECTIVES:
Primary
- 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.
Secondary
- Determine the toxicity profile of this regimen.
OUTLINE: This is a multicenter, open-label, dose-escalation study of erlotinib hydrochloride.
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.
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