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Vinorelbine in Treating Older Women With Stage IV Breast Cancer

Phase II Trial of Oral Vinorelbine for the Treatment of Metastatic Breast Cancer in Patients >65 Years of Age: A Trial of Efficacy, Toxicity, and Patients' Perceived Preference for Oral Therapy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00022152
Enrollment
25
Registered
2003-01-27
Start date
2001-11-30
Completion date
2007-08-31
Last updated
2016-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage IV breast cancer, recurrent breast cancer

Brief 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.

Detailed 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.

Interventions

DRUGvinorelbine tartrate

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
objective response rateUp to 5 years

Secondary

MeasureTime frame
time to progressionUp to 5 years
quality of lifeUp to 5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026