Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT00006260
Brief Summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Drugs such as mesna may be effective in preventing some of the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of etoposide and ifosfamide given with mesna, and cisplatin in treating patients who have metastatic breast cancer.
Detailed Description:
OBJECTIVES:
* Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.
* Determine the tolerability and toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to number of prior chemotherapy courses for metastatic disease (0 vs 1).
Patients receive etoposide IV over 60-90 minutes, cisplatin IV over 30 minutes, and ifosfamide IV over 30 minutes on days 1-3. Mesna is administered IV over 15 minutes 30 minutes prior to and 4 hours after ifosfamide, then orally at 8 hours post infusion. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months.
PROJECTED ACCRUAL: At least 36 patients (16 per stratum) will be accrued over 36 months.
Study:
NCT00006260
Study Brief:
Protocol Section:
NCT00006260