Breast Cancer Clinical Trial

Vinorelbine in Treating Older Women With Stage IV Breast Cancer

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.

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Full Description

OBJECTIVES:

Determine the objective response rate in elderly women with stage IV breast cancer treated with oral vinorelbine.
Determine the toxicity profile of this drug in these patients.
Determine the time to progression in patients treated with this drug.
Determine the quality of life of patients treated with this drug.
Assess individual variation in responses (toxicity and/or activity), pharmacokinetic parameters, and/or biologic correlates due to genetic differences in enzymes involved in the transport, metabolism, and/or mechanism of action of this drug in these patients.

OUTLINE: Patients receive oral vinorelbine once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then after completion of the second course.

Patients are followed every 3 months for 5 years.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT00022152

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 18 Locations for this study

See Locations Near You

CCOP - Scottsdale Oncology Program
Scottsdale Arizona, 85259, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61602, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids Iowa, 52403, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
Siouxland Hematology-Oncology
Sioux City Iowa, 51101, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
CCOP - Ann Arbor Regional
Ann Arbor Michigan, 48106, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CentraCare Health Plaza
Saint Cloud Minnesota, 56303, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68106, United States
Medcenter One Health System
Bismarck North Dakota, 58501, United States
Altru Health Systems
Grand Forks North Dakota, 58201, United States
CCOP - Geisinger Clinic and Medical Center
Danville Pennsylvania, 17822, United States
Rapid City Regional Hospital
Rapid City South Dakota, 57709, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls South Dakota, 57104, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT00022152

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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