Combination Chemotherapy in Treating Patients With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00006260|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 11, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: cisplatin Drug: etoposide Drug: ifosfamide Drug: Mesna||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of An OutPatient Three Day VIP Regimen With Oral Mesna For Metastatic Breast Cancer|
|Study Start Date :||May 1997|
|Actual Primary Completion Date :||January 2005|
- 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.
- Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin. [ Time Frame: Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression. ]
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): NCT00006260
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5055|
|Principal Investigator:||Scot C. Remick, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|