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Sponsors and Collaborators: |
University of Cincinnati Eli Lilly and Company Genentech |
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Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00618826 |
The purpose of this study is to look at a new chemotherapy schedule in metastatic breast cancer.
Condition | Intervention | Phase |
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Metastatic Breast Cancer |
Drug: Paclitaxel Drug: Gemcitabine Drug: Avastin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Biweekly Gemcitabine, Paclitaxel, and Avastin as Frontline Therapy for Metastatic Breast Cancer |
Estimated Enrollment: | 45 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Treatment Period: Experimental
Treatment will be administered once every 2 weeks. One cycle of therapy will consist of 14 days. Paclitaxel is administered first after appropriate premedications. Gemcitabine is administered second and Avastin is administered after chemotherapy, all given on day 1 of each cycle.
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Drug: Paclitaxel
Patients will be premedicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.
Drug: Gemcitabine
Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.
Drug: Avastin
10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions.
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The purpose of this study is to determine whether a new chemotherapy schedule using biweekly combination of paclitaxel (Taxol®), gemcitabine (Gemzar®) and Avastin would help to lessen in-between-cycle growth of resistant cells and to evaluate the toxicity of this therapy.
Taxol is approved by the Food and Drug Administration (FDA) for use in metastatic breast and metastatic ovarian cancer but its use in this study is investigational. Gemzar is FDA approved for the use in breast, lung and pancreatic cancer but its use in this study is investigational.
The Avastin being given in this study is commercially available, however, it has not been approved by FDA for use in metastatic breast cancer.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tammy S Roads | 513-558-2192 | roadst@ucmail.uc.edu |
Contact: Kathleen Havlin, MD | 513-584-5802 | havlinka@ucmail.uc.edu |
United States, Ohio | |
University of Cincinnati Dept. of Medicine, Div. Hem/Onc | Recruiting |
Cincinnati, Ohio, United States, 45267 | |
Contact: Ruth Steele, BS, EMT-P 513-584-2951 ruth.steele@uc.edu | |
Contact: Tammy Roads 513-558-2192 roadst@ucmail.uc.edu | |
Principal Investigator: Kathleen Havlin, MD |
Principal Investigator: | Kathleen Havlin, MD | University of Cincinnati |
Responsible Party: | University of Cincinnati ( University of Cincinnati ) |
Study ID Numbers: | AVF3734s/B9E-US-I158, AVF3734s/B9E-US-I158 |
Study First Received: | February 7, 2008 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00618826 |
Health Authority: | United States: Institutional Review Board |
Breast cancer |
Dexamethasone Promethazine Skin Diseases Paclitaxel Breast Neoplasms |
Bevacizumab Gemcitabine Diphenhydramine Dexamethasone acetate Breast Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors Antimitotic Agents Angiogenesis Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |