NCT00428194

Erlotinib, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB-Stage IVA Cervical Cancer

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	cisplatin	40 mg/m\^2 every 7 days during radiation
DRUG	erlotinib hydrochloride	Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m\^2 by mouth once a day beginning day 1.
PROCEDURE	radiation therapy	standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2007-01-29
• Last updated: 2017-11-29

Locations

1 site across 1 country: United States