Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT00003732|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 12, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of topotecan combined with carboplatin and paclitaxel in treating patients who have stage II, stage III, or stage IV ovarian cancer.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: carboplatin Drug: paclitaxel Drug: topotecan hydrochloride||Phase 2|
- Determine the maximum tolerated dose, dose-limiting toxicity, and quantitative and qualitative toxic effects of oral topotecan combined with intravenous carboplatin and paclitaxel in patients with stage IIB, IIC, III, or IV ovarian epithelial cancer. (phase I closed to accrual 12/21/00)
- Evaluate the anti-tumor activity of this regimen in this patient population.
OUTLINE: This is a multicenter, dose-escalation study of topotecan.
Patients receive oral topotecan on days 1-5 and paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 5. Courses repeat every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
- Phase I: 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 2 of 6 patients experience dose-limiting toxicity. (phase I closed to accrual 12/21/00)
- Phase II: An additional 50 patients receive up to 6 courses of treatment as in phase I at the MTD.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 80 patients (30 in phase I and 50 in phase II) will be accrued for this study. (phase I closed to accrual 12/21/00)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Official Title:||A Phase I/II Study to Determine the Maximum Tolerated Doses of Oral Topotecan, Carboplatin and Paclitaxel Administered Every 21 Days to Patients With Epithelial Ovarian Cancer Stages IIb, IIc, III and IV|
|Study Start Date :||September 1998|
|Actual Study Completion Date :||September 2005|
U.S. FDA Resources
- Maximum tolerated dose and dose-limiting toxicity of topotecan
- Toxic effects
- Antitumor activity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003732
|Rigshospitalet - Copenhagen University Hospital|
|Copenhagen, Denmark, 2100|
|Study Chair:||Svend Aage Engelholm, MD||Rigshospitalet, Denmark|