Full Text View
Tabular View
No Study Results Posted
Related Studies
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   Information provided by Eli Lilly and Company
First Received: April 29, 2002   Last Updated: July 18, 2006   History of Changes

April 29, 2002
July 18, 2006
 
 
 
 
Complete list of historical versions of study NCT00034489 on ClinicalTrials.gov Archive Site
 
 
 
A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer.
A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer.

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.

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.

Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Breast Neoplasms
  • Drug: pemetrexed
  • Drug: gemcitabine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00034489
 
2245, H3E-MC-JMCF
Eli Lilly and Company
 
 
Eli Lilly and Company
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP