Vinorelbine in Treating Older Women With Stage IV Breast Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: vinorelbine tartrate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | 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 |
| Study Start Date: | November 2001 |
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.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 7-18 months.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Arizona | |
| CCOP - Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| United States, Illinois | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61602 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| Siouxland Hematology-Oncology | |
| Sioux City, Iowa, United States, 51101-1733 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Michigan | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| CentraCare Health Plaza | |
| Saint Cloud, Minnesota, United States, 56303 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68106 | |
| United States, North Dakota | |
| Medcenter One Health System | |
| Bismarck, North Dakota, United States, 58501 | |
| Altru Health Systems | |
| Grand Forks, North Dakota, United States, 58201 | |
| United States, Pennsylvania | |
| CCOP - Geisinger Clinic and Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| United States, South Dakota | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57709 | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57104 | |
| Study Chair: | Edith A. Perez, MD | Mayo Clinic |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00022152 History of Changes |
| Other Study ID Numbers: | CDR0000068790, NCCTG-N003A |
| Study First Received: | August 10, 2001 |
| Last Updated: | February 26, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV breast cancer recurrent breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Vinorelbine Vinblastine Antineoplastic Agents, Phytogenic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013