Vinorelbine in Treating Older Women With Stage IV Breast Cancer

• Status: Completed
• Trial end date: 2007-08-01
• 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 vinorelbine in treating older women who have stage IV breast cancer.

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

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Vinblastine; Vinorelbine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed stage IV breast cancer

• Eligible to receive first- or second-line chemotherapy

• At least 1 unidimensionally measurable lesion

• At least 20 mm in longest diameter

• Must be completely outside prior irradiation port unless there is proof of progressive disease after completion of prior radiotherapy

• No untreated brain metastases

• Current metastatic CNS disease allowed only if previously treated and clinically stable at study entry

• No meningeal carcinomatosis

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 65 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

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

Hepatic:

• Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR

• Direct bilirubin normal if total bilirubin elevated or less than 2.5 times ULN because of Gilbert's syndrome

Renal:

• Creatinine no greater than 2 times ULN

Other:

• No grade 2 or greater peripheral neuropathy

• No other significant medical condition that would preclude study

• No active infection within the past 2 weeks

• No dysphagia or inability to swallow intact capsules

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• No more than 1 prior chemotherapy regimen for metastatic disease

• No prior vinca alkaloids

• At least 4 weeks since other prior chemotherapy and recovered

Endocrine therapy:

• Prior hormonal therapy allowed

• No concurrent hormonal therapy

Radiotherapy:

• See Disease Characteristics

• No prior radiotherapy to 25% or more of bone marrow

• At least 3 weeks since prior radiotherapy and recovered

Surgery:

• At least 3 weeks since prior major surgery