|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| 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 | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
| 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 |