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Sponsors and Collaborators: |
Gralow, Julie, M.D. Amgen Bristol-Myers Squibb GlaxoSmithKline |
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Information provided by: | Gralow, Julie, M.D. |
ClinicalTrials.gov Identifier: | NCT00041470 |
The purposes of this are:
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Paclitaxel Drug: Vinorelbine Drug: Trastuzumab Drug: Filgrastim |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial |
Enrollment: | 40 |
Study Start Date: | March 2001 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
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Drug: Paclitaxel
50 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
Drug: Vinorelbine
20 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
Drug: Trastuzumab
4 mg/kg IV loading dose day 1 of first week followed by 2 mg/kg IV maintenance dose on each subsequent week. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
Drug: Filgrastim
5 mcg/kg daily including the day of IV chemotherapy. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION
To be eligible, volunteers must:
EXCLUSION
Patients are not eligible if they:
United States, 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: | 00-5891 |
Study First Received: | July 9, 2002 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00041470 |
Health Authority: | United States: Food and Drug Administration |
Vinorelbine Skin Diseases Paclitaxel |
Trastuzumab Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |