Spots Global Cancer Trial Database for Topotecan in Treating Patients With Gynecologic Cancer That Cannot Be Removed by Surgery

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in treating patients with gynecologic cancer that cannot be removed by surgery.

Detailed Description: OBJECTIVES: Primary * To establish the maximum tolerated dose (MTD) of oral topotecan hydrochloride in patients with unresectable gynecologic malignancies. * To determine the safety and tolerability of this drug in these patients. * To obtain pharmacokinetic data to assess plasma concentrations of this drug when administered at the MTD. Secondary * To explore the response in patients treated with this drug. OUTLINE: Patients receive oral topotecan hydrochloride on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients treated at the maximum tolerated dose undergo blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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