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Sponsors and Collaborators: |
Emory University Sanofi-Aventis |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00674206 |
The purpose of this study is to investigate if the combination of gemcitabine and oxaliplatin is effective for triple negative breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Gemcitabine and oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Gemcitabine and Oxaliplatin for ER-, PR-, HER2NEU- (Triple Negative) Metastatic Breast Cancer |
Estimated Enrollment: | 51 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Single Arm Study: Experimental
All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
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Drug: Gemcitabine and oxaliplatin
Gemcitabine 1000mg/m2 on day 1 every 14 days Oxaliplatin 100mg/m2 on day 2 every 14 days Number of cycles: until progression or unacceptable toxicity develops.
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In this study, participants will receive gemcitabine and oxaliplatin, drugs that have been in use for a long time. Gemcitabine is a treatment that is an effective therapy currently available to patients with this type and stage of breast cancer. Frequently, in cancer therapy, combinations of drugs prove more effective as treatment than the same drugs used alone. The combination of gemcitabine and oxaliplatin has not been tested in patients with triple negative breast cancer. It is hoped that the addition of oxaliplatin may cause your tumor to stop growing or possible your tumor may shrink. This assessment will be basd on measuring changes in the size of your tumor.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate hepatic function as evidenced by:
Exclusion Criteria:
Contact: Amelia Zelnak | 1-888-946-7447 | amelia.zelnak@emoryhealthcare.org |
United States, Georgia | |
Emory University Winship Cancer Institute | Recruiting |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Amelia Zelnak, MD | Emory University Winship Cancer Institute |
Responsible Party: | Winship Cancer Institute ( Amelia Zelnak, MD ) |
Study ID Numbers: | 7792 |
Study First Received: | May 6, 2008 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00674206 History of Changes |
Health Authority: | United States: Institutional Review Board |
Metastatic breast cancer |
Antimetabolites Oxaliplatin Radiation-Sensitizing Agents Immunologic Factors Skin Diseases |
Breast Neoplasms Gemcitabine Immunosuppressive Agents Antiviral Agents Breast Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Enzyme Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Oxaliplatin Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Gemcitabine Breast Diseases |