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NCT00034489 Clinical Trial

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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00034489
Other study ID # 2245
Secondary ID H3E-MC-JMCF
Status Completed
Phase Phase 2
First received April 29, 2002
Last updated July 18, 2006

Study information
Verified date July 2006
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• pemetrexed

• gemcitabine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

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