A Phase II Study Of An OutPatient Three Day VIP Regimen With Oral Mesna For Metastatic Breast Cancer
N/A
N/A
Both
Breast Cancer
Trial Information
A Phase II Study Of An OutPatient Three Day VIP Regimen With Oral Mesna For Metastatic Breast Cancer
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven progressive metastatic breast cancer
- Measurable disease
- Any lesion measurable in 2 dimensions
- Hepatic metastases if the sum of the measurements below the costal margin in the
midclavicular line and the tip to the xiphoid process is greater than 5 cm
during quiet respiration
- Hepatic defects that are clearly measurable by radionuclide, CAT, or MRI scans
- Bone metastases are not considered measurable disease
- Evaluable disease allowed if measurable disease also present
- No brain metastases, carcinomatous meningitis, or spinal cord compression
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Not specified
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Hemoglobin at least 10 g/dL
- WBC at least 4,000/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
Renal:
- Creatinine no greater than 1.5 mg/dL
- No bladder outlet obstruction
Cardiovascular:
- No symptomatic cardiovascular disease (e.g., congestive heart disease) or inability
to tolerate a fluid load
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection
- No prior malignancies except adequately treated basal or squamous cell skin cancer or
carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No greater than 1 prior biologic response modifier treatment for metastatic disease
Chemotherapy:
- No greater than 1 prior chemotherapy regimen for metastatic disease allowed
- Patients who relapsed during or within 6 months after adjuvant chemotherapy are
considered to have failed 1 regimen
- Patients who relapsed more than 6 months after adjuvant chemotherapy are considered
to not have had a prior regimen
- Greater than 4 weeks since prior chemotherapy (greater than 6 weeks for mitomycin or
nitrosoureas) and recovered
- No prior cisplatin, etoposide, or ifosfamide
Endocrine therapy:
- Prior medical or surgical hormonal therapy allowed
Radiotherapy:
- Prior radiation therapy to areas of measurable disease allowed if indicator lesion
increased in size by greater than 25% after treatment
- Recovered from effects of prior radiotherapy
Surgery:
- Recovered from effects of major surgery
Other:
- At least 7 days since prior nephrotoxic drugs (e.g., aminoglycosides, diuretics,
lithium, intravenous contrast, or nonsteroidal antiinflammatory drugs)
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.
Outcome Time Frame:
Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.
Safety Issue:
No
Principal Investigator
Scot C. Remick, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CWRU4196
NCT ID:
NCT00006260
Start Date:
May 1997
Completion Date:
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
