A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer.
18 Years
N/A
Female
Breast Neoplasms
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
2245
NCT ID:
NCT00034489
Start Date:
Completion Date:
Related Keywords:
- Breast Neoplasms
- metastatic breast cancer
- combination therapy
- Alimta
- Breast Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Alexandria, Minnesota 56308 |
