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Sponsored by: |
Ohio State University Comprehensive Cancer Center |
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Information provided by: | Ohio State University Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00201760 |
This study determines the proportion of metastatic breast cancer patients progression free after 6 months when treated with gemcitabine/ cisplatin/ trastuzumab or gemcitabine/ trastuzumab.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Gemcitabine Drug: Trastuzumab Drug: Cisplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Phase II Study of Gemcitabine/ Trastuzumab and Gemcitabine/ Cisplatin/ Trastuzumab in Patients With Metastatic Breast Cancer |
Estimated Enrollment: | 62 |
Study Start Date: | February 2005 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Gemcitabine/Cisplatin/Trastuzumab
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Drug: Gemcitabine
1000 mg/m2 IV over 30 minutes on Days 1 and 8.
Drug: Trastuzumab
2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.
Drug: Cisplatin
30 mg/m2 IV on Day 1 and Day 8.
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2: Active Comparator
Gemcitabine/Trastuzumab
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Drug: Gemcitabine
1000 mg/m2 IV over 30 minutes on Days 1 and 8.
Drug: Trastuzumab
2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.
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Rationale: Previous studies have demonstrated the anti-tumor efficacy of gemcitabine and trastuzumab against metastatic breast cancer when given alone and in combination. Yet, research indicates that the two drugs given together work more effectively than either alone. Laboratory studies testing the combination of trastuzumab and cisplatin have shown synergistic anti-tumor activity with the two drugs. In addition, clinical studies suggest a high level of anti-tumor activity with the combination of gemcitabine and cisplatin. Researchers are testing the triple drug combination of gemcitabine, trastuzumab, and cisplatin in the current study to evaluate the potential for enhanced responsiveness in patients with Her-2/neu overexpressing breast cancer as well as comparing it to the double drug combination of gemcitabine and trastuzumab.
Purpose: This study will measure patient responses and compare the efficacy of a double drug combination (gemcitabine and trastuzumab) with a triple drug combination (gemcitabine, trastuzumab, and cisplatin) in patients with metastatic breast cancer. Side effects will be carefully assessed in patients.
Treatment: Patients in this study will receive one of two treatment combinations. A computer will randomly assign patients to a treatment group. Group one will be given gemcitabine and trastuzumab. Gemcitabine will be given to patients on days 1 and 8, and trastuzumab on days 1, 8, and 15. Group two will receive gemcitabine, trastuzumab, and cisplatin. Gemcitabine and cisplatin will both be administered on days 1 and 8, and trastuzumab on days 1, 8, and 15. Each treatment cycle (for both groups) will last a total of 21 days. All study drugs will be administered through intravenous infusions. Several tests and exams will be given throughout the study to closely monitor patients. Thorough patient exams will be given at the beginning of each treatment cycle. Imaging tests will be done every two cycles for the first eight cycles and then every three cycles until study completion. Study treatment will be discontinued due to disease growth or unacceptable side effects.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
United States, Ohio | |
Ohio State University | |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Kari Kendra | Ohio State University |
Responsible Party: | Ohio State University Comprehensive Cancer Center ( Kari Kendra, M.D. ) |
Study ID Numbers: | OSU-0342 |
Study First Received: | September 12, 2005 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00201760 History of Changes |
Health Authority: | United States: Institutional Review Board |
metastatic |
Antimetabolites Immunologic Factors Skin Diseases Breast Neoplasms Antiviral Agents Immunosuppressive Agents Antibodies, Monoclonal |
Antibodies Cisplatin Radiation-Sensitizing Agents Trastuzumab Gemcitabine Breast Diseases Immunoglobulins |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Enzyme Inhibitors Immunosuppressive Agents |
Antiviral Agents Pharmacologic Actions Antibodies, Monoclonal Neoplasms Neoplasms by Site Cisplatin Radiation-Sensitizing Agents Therapeutic Uses Trastuzumab Gemcitabine Breast Diseases |