Capecitabine and Paclitaxel in Treating Patients With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2004-09-01
• 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.

PURPOSE: Phase I/II trial to determine the effectiveness of combining capecitabine and paclitaxel in treating patients who have metastatic breast cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Albumin-Bound Paclitaxel; Capecitabine; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed metastatic adenocarcinoma of the breast

• Patients in phase I:

• Evaluable disease

• Patients in phase II:

• Bidimensionally measurable disease

• Bone metastases are not considered measurable

• No known or clinically suspected CNS metastases

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 to 64

Sex:

• Not specified

Menopausal status:

• Not specified

Performance status:

• WHO 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• WBC greater than 3,500/mm^3

• Platelet count greater than 100,000/mm^3

• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST/ALT no greater than 2 times ULN (3 times ULN if liver metastases present)

Renal:

• Patients in phase I:

• Creatinine clearance at least 50 mL/min

• Patients in phase I or II:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No grade 2 or greater atrioventricular block

Other:

• No cognitive impairment or severe psychiatric disorder

• No greater than grade 2 preexisting peripheral neuropathy

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

• Able to tolerate steroid premedication

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• More than 6 months since prior adjuvant chemotherapy

• At least 1 year since prior continuous infusion of fluorouracil or capecitabine

• At least 1 year since prior taxane administered once every 3 weeks

• No prior taxane or capecitabine administered weekly

• No more than 1 prior chemotherapy regimen for metastatic or locally advanced breast cancer

• No other concurrent chemotherapy

Endocrine therapy:

• Prior hormonal treatment for metastatic breast cancer allowed

• No concurrent continuous glucocorticosteroids

• No concurrent systemic endocrine treatment for breast cancer

Radiotherapy:

• No concurrent radiotherapy to indicator lesion or more than 30% of bone marrow

Surgery:

• Not specified

Other:

• No other concurrent anticancer treatment

• No concurrent immunosuppressive drugs

• Concurrent bisphosphonates allowed if indicator lesion is non-bone

• Able to tolerate steroid premedication