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Sponsors and Collaborators: |
Sarah Cannon Research Institute SCRI Oncology Research Consortium Sanofi-Aventis |
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Information provided by: | Sarah Cannon Research Institute |
ClinicalTrials.gov Identifier: | NCT00297596 |
This is a phase II study of the combination of oxaliplatin and trastuzumab as first or second line therapy in patients with stage IV, metastatic breast cancer
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Trastuzumab Drug: Oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Trastuzumab and Oxaliplatin in Patients With Metastatic Breast Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Eligible patients will receive a minimum of six cycles of combination therapy. If a patient is still responding to the oxaliplatin at 6 cycles, the oxaliplatin may be continued with the trastuzumab up to 10 cycles at the investigator's discretion. After discontinuing the oxaliplatin/trastuzumab combination, patients should continue with single agent trastuzumab until disease progression. Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes. Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab |
Drug: Trastuzumab
Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
Drug: Oxaliplatin
Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab |
Eligible patients will receive a minimum of six cycles of combination therapy. If a patient is still responding to the oxaliplatin at 6 cycles, the oxaliplatin may be continued with the trastuzumab up to 10 cycles at the investigator's discretion. After discontinuing the oxaliplatin/trastuzumab combination, patients should continue with single agent trastuzumab until disease progression.
Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes. Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles.
For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Kentucky | |
Graves-Gilbert Clinic | |
Bowling Green, Kentucky, United States, 42101 | |
United States, Louisiana | |
Baton Rouge General Medical Center | |
Baton Rouge, Louisiana, United States, 70806 | |
Hematology Oncology Life Center | |
Alexandria, Louisiana, United States, 71301 | |
United States, Ohio | |
Oncology Hematology Care | |
Cincinnati, Ohio, United States, 45242 | |
United States, South Carolina | |
Spartanburg Regional Medical Center | |
Spartanburg, South Carolina, United States, 29303 | |
United States, Tennessee | |
Tennessee Oncology, PLLC | |
Nashville, Tennessee, United States, 37205 | |
Chattanooga Oncology and Hematology Associates | |
Chattanooga, Tennessee, United States, 37404 |
Principal Investigator: | Denise A. Yardley, MD | Sarah Cannon Research Institute |
Responsible Party: | Sarah Cannon Research Institute ( Denise A. Yardley, M.D. ) |
Study ID Numbers: | SCRI BRE 77 |
Study First Received: | February 24, 2006 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00297596 |
Health Authority: | United States: Food and Drug Administration |
Metastatic HER2/neu+ |
Oxaliplatin Skin Diseases Trastuzumab Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |