Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer

• Status: Terminated
• 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. It is not yet known if capecitabine is more effective than vinorelbine in treating metastatic breast cancer.

PURPOSE: Randomized phase II/III trial to compare the effectiveness of capecitabine with that of vinorelbine in treating women who have metastatic breast cancer that has been previously treated with chemotherapy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Capecitabine; Vinblastine; Vinorelbine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer

• Metastatic disease

• Prior treatment with taxanes in the metastatic, adjuvant, or neoadjuvant setting

• Taxane-resistant disease allowed regardless of duration of prior therapy NOTE:

Resistant disease defined as progression during or within 12 weeks after taxane therapy for metastatic disease or a disease-free interval of less than 12 months after neoadjuvant or adjuvant therapy with a taxane

• Taxane-sensitive disease allowed if at least 4 prior courses were received NOTE:

Sensitive disease defined as progression occurring more than 12 weeks after taxane therapy for metastatic disease or more than 12 months after neoadjuvant or adjuvant therapy with a taxane

• Prior treatment with anthracyclines for metastatic disease or as adjuvant treatment OR medical contraindication to treatment with anthracyclines

• At least one unidimensionally measurable lesion (phase II study)

• 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

• Not specified

Hematopoietic

• Absolute 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)

• Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present)

Renal

• Creatinine clearance greater than 50 mL/min

Cardiovascular

• No symptomatic ventricular arrhythmias

• No clinically significant congestive heart failure

• No clinical or ECG evidence of myocardial infarction within the past 12 months

• No significant coronary artery disease

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No prior malignancy within the past 5 years except contralateral breast cancer, nonmelanoma skin cancer, and adequately treated carcinoma in situ of the cervix

• No known or prior sensitivity to fluoropyrimidines, including fluorouracil

• No pre-existing grade 2 or greater neurotoxicity

• No known malabsorption or upper gastrointestinal abnormalities that would affect absorption of study drug

• No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent biologic therapy

Chemotherapy

• See Disease Characteristics

• No more than 2 prior chemotherapy lines for metastatic disease

• No prior capecitabine, vinca alkaloids, or continuous fluorouracil

• No other concurrent chemotherapy

Endocrine therapy

• Prior hormonal therapy allowed

• No concurrent hormonal therapy

Radiotherapy

• No concurrent radiotherapy

Surgery

• Not specified

Other

• Bisphosphonate therapy for treatment and prevention of bony metastases allowed if initiated prior to study

• No other concurrent investigational treatment

• No concurrent brivudine with capecitabine