NCT00054444

Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer

A PHASE I STUDY OF PELVIC RADIATION THERAPY WITH CONCOMITANT WEEKLY CISPLATIN AND TOPOTECAN CHEMOTHERAPY IN PATIENTS WITH CERVICAL CARCINOMA WITHOUT EXTRA-PELVIC METASTASIS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase I trial is studying the side effects and best way to give radiation therapy when given together with topotecan and cisplatin in treating patients with locally advanced cervical cancer. This trial is also studying the best dose of topotecan when given in this regimen. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as topotecan and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. Determine the safety and tolerability of pelvic radiotherapy, cisplatin, and topotecan in patients with locally advanced cervical cancer. II. Determine the maximum tolerated dose (MTD) of topotecan when administered in this regimen in this patient population. SECONDARY OBJECTIVES: I. Determine the site of recurrence (local vs distant) in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of topotecan. Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive cisplatin IV and topotecan IV over 30 minutes once weekly for a total of 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 1 of 6 patients experiences dose-limiting toxicity. Once the MTD is determined, an additional cohort of 20 patients receives treatment as above at the MTD. After completion of study treatment, patients are followed periodically for 5 years.

Conditions

• Cervical Adenocarcinoma
• Cervical Squamous Cell Carcinoma
• Stage IB Cervical Cancer
• Stage IIA Cervical Cancer
• Stage IIB Cervical Cancer
• Stage III Cervical Cancer
• Stage IVA Cervical Cancer

Interventions

Type	Name	Description
DRUG	Topotecan Hydrochloride Liposomes	Given IV
RADIATION	3-Dimensional Conformal Radiation Therapy
DRUG	Cisplatin	Given IV

Timeline

• Start date: 2007-09-01
• Primary completion: 2012-01-01
• First posted: 2003-02-06
• Last updated: 2014-12-31

Locations

10 sites across 1 country: United States