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| Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00022152 |
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 ditartrate |
Phase II |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer |
| Drug Information available for: | Vinorelbine Vinorelbine tartrate |
| Study Type: | Interventional |
| Study Design: | 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:
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:
At least 1 unidimensionally measurable lesion
No untreated brain metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Arizona | |||||
| CCOP - Scottsdale Oncology Program | |||||
| Scottsdale, Arizona, United States, 85259-5404 | |||||
| United States, Illinois | |||||
| CCOP - Carle Cancer Center | |||||
| Urbana, Illinois, United States, 61801 | |||||
| CCOP - Illinois Oncology Research Association | |||||
| Peoria, Illinois, United States, 61602 | |||||
| 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 | |||||
| CCOP - Metro-Minnesota | |||||
| Saint Louis Park, Minnesota, United States, 55416 | |||||
| CentraCare Health Plaza | |||||
| Saint Cloud, Minnesota, United States, 56303 | |||||
| Mayo Clinic Cancer Center | |||||
| Rochester, Minnesota, United States, 55905 | |||||
| United States, Nebraska | |||||
| CCOP - Missouri Valley Cancer Consortium | |||||
| Omaha, Nebraska, United States, 68106 | |||||
| United States, North Dakota | |||||
| Altru Health Systems | |||||
| Grand Forks, North Dakota, United States, 58201 | |||||
| Medcenter One Health System | |||||
| Bismarck, North Dakota, United States, 58501 | |||||
| United States, Pennsylvania | |||||
| CCOP - Geisinger Clinic and Medical Center | |||||
| Danville, Pennsylvania, United States, 17822-2001 | |||||
| United States, South Dakota | |||||
| CCOP - Sioux Community Cancer Consortium | |||||
| Sioux Falls, South Dakota, United States, 57104 | |||||
| Rapid City Regional Hospital | |||||
| Rapid City, South Dakota, United States, 57709 | |||||
| North Central Cancer Treatment Group |
| National Cancer Institute (NCI) |
| Study Chair: | Edith A. Perez, MD | Mayo Clinic |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068790, NCCTG-N003A |
| First Received: | August 10, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00022152 |
| Health Authority: | United States: Federal Government |
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