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Home > "V" Clinical Trials Conditions > Vinorelbine and Docetaxel in Treating Women With Metastatic Breast Cancer  Vinorelbine and Docetaxel in Treating Women With Metastatic Breast Cancer
Vinorelbine and Docetaxel in Treating Women With Metastatic Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): Washington Hospital Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of vinorelbine combined with docetaxel in treating women who have metastatic breast cancer.
Details: OBJECTIVES: I. Determine the response rate in women with metastatic breast cancer treated with vinorelbine and docetaxel. II. Determine the time to disease progression, time to treatment failure, response duration, and survival in this patient population treated with this regimen. PROTOCOL OUTLINE: This is a multicenter study. Patients receive vinorelbine IV on days 1 and 8, and docetaxel IV over 1 hour on day 1 only. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed for 1 month, and then every 1.5-3 months for 1 year. PROJECTED ACCRUAL: Approximately 69 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed stage IV breast cancer - Disease progression following prior adjuvant chemotherapy (no disease progression during treatment with prior doxorubicin) - Bidimensionally measurable disease; Prior radiotherapy allowed if disease completely outside radiation port or histologic evidence of measured area indicating malignancy and not radiation fibrosis - No CNS metastases; Brain metastases previously treated with radiotherapy or surgical excision allowed if no evidence of residual metastases on brain CT or MRI - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: At least 7 days since prior hematopoietic growth factors (filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa); At least 7 days since prior platelet transfusion - Chemotherapy: See Disease Characteristics No prior vinca alkaloids (including vinorelbine or docetaxel); No other concurrent antineoplastic agents - Endocrine therapy: No concurrent anticancer hormonal agents - Radiotherapy: See Disease Characteristics; No concurrent palliative radiotherapy - Surgery: See Disease Characteristics - Other: No other concurrent investigational drug or device --Patient Characteristics-- - Age: Over 18 - Sex: Female - Menopausal status: Premenopausal or postmenopausal - Performance status: ECOG 0-1 - Life expectancy: Greater than 16 weeks - Hematopoietic: WBC at least 2,000/mm3; Platelet count greater than 100,000/mm3; Hemoglobin greater than 9 g/dL - Hepatic: Bilirubin less than 2.0 mg/dL; SGOT/SGPT less than 1.5 times upper limit of normal (ULN); Alkaline phosphatase less than 2.5 times ULN - Renal: Not specified - Cardiovascular: No symptomatic New York Heart Association class II or greater congestive heart failure; No significant arrhythmia requiring drug therapy; No myocardial infarction within the past 6 months; No uncontrolled cardiac disease or unstable angina - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix; No preexisting clinically significant peripheral neuropathy (no prior neuropathy of any grade if previously treated with paclitaxel); No unstable, preexisting medical condition; No serious active infection; No other underlying medical, psychological, familial, sociologic, or geographic condition that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidPerry, Study Chair, Washington Hospital Center
Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
United States
Additional Information:
Study ID Numbers: CDR0000068284; WHC-2000056,NCI-V00-1631
Study Start Date: February 2000
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006682
Other Stage 4 Breast Cancer Studies:
1. Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer
2. Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
3. Docetaxel and Epirubicin With and Without G-CSF in Treating Women With Metastatic Breast Cancer
4. Suramin and Paclitaxel in Treating Women With Stage IIIB or Stage IV Breast Cancer
5. Paclitaxel With or Without Trastuzumab in Treating Patients With Inoperable, Recurrent, or Metastatic Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
Vinorelbine and Docetaxel in Treating Women With Metastatic Breast Cancer
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