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Home > "V" Clinical Trials Conditions > Vinorelbine in Treating Older Women With Stage IV Breast Cancer  Vinorelbine in Treating Older Women With Stage IV Breast Cancer
Vinorelbine in Treating Older Women With Stage IV Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 65 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdithPerez, Study Chair, Mayo Clinic Cancer Center
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CentraCare Health Plaza
St. Cloud, Minnesota, 56303
United States
Additional Information:
Study ID Numbers: CDR0000068790; NCCTG-N003A
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022152
Other Recurrent Breast Cancer Studies:
1. Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
2. Anastrozole With or Without Trastuzumab in Treating Postmenopausal Women With Metastatic Breast Cancer
3. Chemotherapy in Treating Patients With Breast Cancer
4. Capecitabine and Paclitaxel in Treating Patients With Metastatic Breast Cancer
5. Allogeneic Peripheral Stem Cell Transplantation After Antithymocyte Globulin, High-Dose Melphalan, and Fludarabine in Treating Women With Metastatic Adenocarcinoma of the Breast
Related Studies:
Other recurrent breast cancer Clinical Trials
Other South Dakota Clinical Trials
Other Rapid City Clinical Trials
Vinorelbine in Treating Older Women With Stage IV Breast Cancer
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