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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
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.
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Maximum tolerated dose (MTD)
Time frame: Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity.
Safety and tolerability
Time frame: Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity.
Plasma concentration of topotecan hydrochloride when administered at the MTD
Time frame: blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies
Response
Time frame: Treatment repeats every 28 days for up to 6 courses in the absence of disease progression.
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