Trials / Completed
CompletedNCT00842452
Topotecan in Treating Patients With Gynecologic Cancer That Cannot Be Removed by Surgery
A Phase I Study of Weekly Oral Topotecan in Gynecologic Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Steven Waggoner, MD · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Cervical Cancer
- Endometrial Cancer
- Fallopian Tube Cancer
- Ovarian Cancer
- Sarcoma
- Vaginal Cancer
- Vulvar Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | topotecan hydrochloride | 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. |
| OTHER | pharmacological study | Patients treated at the maximum tolerated dose undergo blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies. |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2011-04-01
- Completion
- 2011-04-01
- First posted
- 2009-02-12
- Last updated
- 2013-04-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00842452. Inclusion in this directory is not an endorsement.