NCT00287911

Topotecan, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Cervical Cancer

A Phase I Study of Adjuvant Topotecan and Cisplatin With Concurrent Radiation Therapy for Advanced Cervical Cancer

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

Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan and 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. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Topotecan and cisplatin may make tumor cells more sensitive to radiation therapy. Giving topotecan and cisplatin together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with cisplatin and radiation therapy in treating patients with advanced cervical cancer.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose of topotecan when administered with cisplatin in patients with advanced cervical cancer. * Identify any unique toxicities associated with administering radiotherapy along with adjuvant cisplatin and topotecan in patients with cervical cancer. * Determine the feasibility of administering continuous infusion topotecan chemotherapy together with radiation therapy. * Assess the quality of life of patients treated with this regimen. OUTLINE: This is a dose-escalation study of topotecan. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36. Some patients may also undergo brachytherapy. Patients also receive cisplatin intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36 and topotecan IV continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36. Treatment continues 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 preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Quality of life is assessed at baseline and at 4 and 14 weeks after completion of study treatment. After completion of study treatment, patients are followed periodically.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	cisplatin	intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36
DRUG	topotecan hydrochloride	intravenously continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36 -Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined
RADIATION	brachytherapy	Some patients may also undergo brachytherapy
RADIATION	radiation therapy	once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36

Timeline

• Start date: 2005-02-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2006-02-07
• Last updated: 2017-12-02

Locations

1 site across 1 country: United States