Combination Chemotherapy in Treating Patients With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Mesna

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)