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| Sponsored by: |
Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00034489 |
Purpose
This is a study to explore how well the combination of LY231514 and Gemcitabine work together in patients with breast cancer that has spread beyond the location of the original tumor. Patients must have previously received treatment with anthracycline and taxane chemotherapy drugs.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Drug: pemetrexed Drug: gemcitabine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer. |
Gemcitabine is given by vein over 30 minutes on days 1 & 8 of each 21-day cycle. LY231514 is also given by vein over 10 minutes on day 8, following the Gemcitabine injection. Vitamin supplementation with oral folic acid and injectable B12 is initiated 7-10 days prior to the first dose of LY231514, and continuing throughout the patient's participation. Vitamin B12 is administered approximately every 9 weeks after the first injection.
Appropriate antiemetic medication should be given to all patients. Dexamethasone 4mg PO twice daily is given for 3 days per cycle, beginning 1 day prior to LY231514 dosing. This is given to prevent or lessen the possibility of a rash.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | 2245, H3E-MC-JMCF |
| Study First Received: | April 29, 2002 |
| Last Updated: | July 18, 2006 |
| ClinicalTrials.gov Identifier: | NCT00034489 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
metastatic breast cancer combination therapy Alimta |
|
Antimetabolites Anti-Infective Agents Skin Diseases Immunologic Factors Folate Breast Neoplasms Folinic Acid Folic Acid Antagonists |
Antiviral Agents Immunosuppressive Agents Vitamin B9 Pemetrexed Folic Acid Radiation-Sensitizing Agents Gemcitabine 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 Folic Acid Antagonists |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Pemetrexed Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Gemcitabine Breast Diseases |
