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Sponsors and Collaborators: |
University of Washington Aventis Pharmaceuticals |
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Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00194740 |
The two drugs used to treat metastatic breast cancer in this study may perform better when used together than when used separately. The use of another drug that prevents the most common side effect of the two-drug combination permits the delivery of both agents at closer to the "full" dose for either when used alone. We hypothesize that the two-drug combination used with G-CSF support will be more effective and less toxic than other standard regimens for the treatment of metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Neoplasm |
Drug: Docetaxel Drug: Vinorelbine Drug: Filgrastim |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Taxotere Plus Weekly Navelbine and G-CSF: A Phase II Study in Stage IV Breast Cancer |
Enrollment: | 48 |
Study Start Date: | November 1997 |
Study Completion Date: | June 2007 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Docetaxel
60 mg/m2, IV, day 1 of each 21 day cycle
Drug: Vinorelbine
27.5 mg/m2, IV, days 8 & 15 of each 21 day cycle
Drug: Filgrastim
5 µg/kg/day s.c., to be administered days 2-21 of each cycle.
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Preclinical data suggest that there may be synergy between vinorelbine and paclitaxel when the two drugs are used in combination such that the effect of the two together may be better than either alone. Clinical data suggest that the use of concurrent G-CSF with paclitaxel and vinorelbine permits the delivery of both agents at approximately 70% of the "full" dose for either, used alone without G-CSF support, with myelosuppression as the usual dose-limiting toxicity and no unusual or unexpected complications. Encouragingly, 8/20 (40%) patients had objective responses, with three complete remissions (15%) in this program of third-line therapy. Therefore, we now propose to combine docetaxel at about 70% of "full" dose with vinorelbine at 27.5 mg/m2, the "phase II" dose defined in the previous trial. Docetaxel will be given on day 1 followed by vinorelbine on days 8 and 15, with G-CSF to be administered on all days except that of docetaxel administration. The cycle is to be repeated every three weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients are excludes if their:
Patients are excluded if they are:
Patients are excluded if they have:
United States, Washington | |
University of Washington/Seattle Cancer Care Alliance | |
Seattle, Washington, United States, 98109-1023 |
Principal Investigator: | Julie R. Gralow, M.D. | University of Washington |
Responsible Party: | University of Washington ( Julie Gralow, M.D. ) |
Study ID Numbers: | 97-5372-A |
Study First Received: | September 14, 2005 |
Last Updated: | December 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00194740 |
Health Authority: | United States: Institutional Review Board |
Breast cancer |
Docetaxel Vinorelbine Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Antineoplastic Agents, Phytogenic Pharmacologic Actions |