NCT00006260

Combination Chemotherapy in Treating Patients With Metastatic Breast Cancer

A Phase II Study Of An OutPatient Three Day VIP Regimen With Oral Mesna For Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	cisplatin	cisplatin IV over 30 minutes on days 1-3.
DRUG	etoposide	etoposide IV over 60-90 minutes on days 1-3.
DRUG	ifosfamide	ifosfamide IV over 30 minutes on days 1-3.
DRUG	Mesna	Mesna is administered IV over 15 minutes 30 minutes prior to and 4 hours after ifosfamide, then orally at 8 hours post infusion.

Timeline

• Start date: 1997-05-01
• Primary completion: 2005-01-01
• First posted: 2003-01-27
• Last updated: 2010-06-11

Locations

1 site across 1 country: United States