- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00022152
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
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85259-5404
- CCOP - Scottsdale Oncology Program
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Illinois
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Peoria, Illinois, United States, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, United States, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, United States, 50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, United States, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
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Michigan
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Ann Arbor, Michigan, United States, 48106
- CCOP - Ann Arbor Regional
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Minnesota
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Duluth, Minnesota, United States, 55805
- CCOP - Duluth
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, United States, 56303
- CentraCare Health Plaza
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Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, United States, 68106
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck, North Dakota, United States, 58501
- Medcenter One Health System
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Grand Forks, North Dakota, United States, 58201
- Altru Health Systems
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Pennsylvania
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Danville, Pennsylvania, United States, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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South Dakota
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Rapid City, South Dakota, United States, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, United States, 57104
- CCOP - Sioux Community Cancer Consortium
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: vinorelbine
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
objective response rate
Time Frame: Up to 5 years
|
Up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
quality of life
Time Frame: Up to 5 years
|
Up to 5 years
|
time to progression
Time Frame: Up to 5 years
|
Up to 5 years
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCCTG-N003A
- NCI-2012-02395 (Registry Identifier: CTRP (Clinical Trials Reporting System))
- CDR0000068790 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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