Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer
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.
Drug: topotecan hydrochloride
|Study Design:||Primary Purpose: Treatment|
|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|
- Maximum tolerated dose and dose-limiting toxicity of topotecan [ Designated as safety issue: Yes ]
- Toxic effects [ Designated as safety issue: Yes ]
- Antitumor activity [ Designated as safety issue: No ]
|Study Start Date:||September 1998|
|Study Completion Date:||September 2005|
- 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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003732
|Rigshospitalet - Copenhagen University Hospital|
|Copenhagen, Denmark, 2100|
|Study Chair:||Svend Aage Engelholm, MD||Rigshospitalet, Denmark|