Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel and ifosfamide in treating women who have metastatic breast cancer.

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

Details

• Lead Sponsor: Grupo Oncologico Cooperativo del Sur
• Treatments: Docetaxel; Ifosfamide; Isophosphamide mustard

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic breast cancer

• Bidimensionally measurable lesions

• The following are not considered measurable:

• Bone lesions

• Leptomeningeal disease

• Ascites

• Pleural/pericardial effusion

• Inflammatory breast disease

• Lymphangitis cutis/pulmonis

• Disease progression after hormonal therapy allowed provided at least 1 month since last therapeutic manipulation

• No CNS metastases

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 21 to 75

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-2 OR

• Zubrod 0-2

Life expectancy:

• More than 12 weeks

Hematopoietic:

• WBC at least 4,000/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 11 g/dL

Hepatic:

• Bilirubin no greater than 1.25 times upper limit of normal (ULN)

• SGOT no greater than 1.25 times ULN

Renal:

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No history of congestive heart failure

• No myocardial infarction within the past 6 months

• No active ischemic heart disease

• No uncontrolled hypertension

Other:

• Not pregnant

• No other prior or concurrent malignancy except properly treated basal cell skin cancer or carcinoma in situ of the cervix

• No other medical or psychiatric diseases that would preclude study

• No geographical situation that would preclude study

• No history of alcohol abuse

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior adjuvant chemotherapy including ifosfamide or docetaxel

• No prior systemic chemotherapy for metastatic breast cancer

Endocrine therapy:

• See Disease Characteristics

• No concurrent corticoids, gestagens, or androgens unless strictly indicated

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No concurrent drinks containing caffeine or alcohol