Capecitabine in Treating Women With Advanced or 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: Randomized phase II trial to compare the effectiveness of two different doses of capecitabine in treating women who have advanced or metastatic breast cancer.

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

Details

• Lead Sponsor: Pharmatech Oncology
• Treatments: Capecitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically and/or cytologically confirmed breast cancer

• Advanced and/or metastatic disease

• At least 1 measurable lesion

• At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

• No CNS metastases

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Karnofsky 70-100%

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Neutrophil count at least 1,500/mm^3

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

Hepatic:

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

• AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)

• Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present OR 10 times ULN if bone metastases present)

• No hepatitis

Renal:

• Creatinine no greater than 1.5 times ULN

• Creatinine clearance at least 50 mL/min

Cardiovascular:

• No clinically significant cardiac disease

• No congestive heart failure

• No symptomatic coronary artery disease

• No cardiac arrhythmias poorly controlled with medication

• No myocardial infarction within the past 12 months even if adequately controlled with medication

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No severe pain inadequately controlled by analgesics

• No prior severe and unexpected reaction to fluoropyrimidine therapy

• No known hypersensitivity to fluorouracil

• No impaired physical integrity of the upper gastrointestinal tract

• No malabsorption syndrome

• No inability to swallow tablets

• No history of uncontrolled seizures, central nervous system disorder, or psychiatric disability that would preclude study participation

• No serious uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 2 but no more than 3 prior chemotherapy regimens

• At least 1 prior chemotherapy regimen containing paclitaxel and an anthracycline as adjuvant therapy or for advanced and/or metastatic disease

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to target lesions unless there is evidence of new disease within the irradiated field

• No concurrent radiotherapy

Surgery:

• No prior organ allografts

Other:

• At least 4 weeks since prior investigational drug

• No concurrent enrollment on other investigational study

• No other concurrent anticancer agents