A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer. - Tabular View

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A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer.

This study has been completed.

Study NCT00034489. Last updated on July 18, 2006. Information provided by Eli Lilly and Company

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer.
Official Title ^†	A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer.
Brief Summary	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.
Detailed Description	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.
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Breast Neoplasms
Intervention ^†	Drug: pemetrexed Drug: gemcitabine
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†
Start Date ^†
Completion Date
Eligibility Criteria ^†	Inclusion Criteria: confirmed diagnosis of breast cancer measurable disease received prior anthracycline and taxane life expectancy > 3 months acceptable lab results Exclusion Criteria: >3 prior regimens prior treatment with protocol drugs prior (pelvic) radiation active CNS metastasis inability to take oral vitamins
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00034489
Organization ID	2245
Secondary IDs ^††	H3E-MC-JMCF
Study Sponsor ^†	Eli Lilly and Company
Collaborators ^††
Investigators ^†
Information Provided By	Eli Lilly and Company
Verification Date	July 2006
First Received Date ^†	April 29, 2002
Last Updated Date	July 18, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.