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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 |
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Breast Neoplasms |
Drug: pemetrexed Drug: gemcitabine |
Phase II |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer |
| Drug Information available for: | Gemcitabine hydrochloride Gemcitabine Pemetrexed disodium Pemetrexed |
| 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 |
| First Received: | April 29, 2002 |
| Last Updated: | July 18, 2006 |
| ClinicalTrials.gov Identifier: | NCT00034489 |
| Health Authority: | United States: Food and Drug Administration |
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