Status:
COMPLETED
A Study of Biweekly Pemetrexed and Gemcitabine in Patients With Metastatic Breast Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This study is designed to determine the efficacy of the biweekly pemetrexed/gemcitabine regimen when given to patients with metastatic breast cancer. Each agent has well demonstrated antitumor activit...
Eligibility Criteria
Inclusion
- INCLUSION:
- Have a performance status of 0 to 2 on the ECOG performance status schedule.
- Patients may have had up to one prior systemic chemotherapy for metastatic disease is allowed. Prior adjuvant therapy is allowed if it has been more than one year since the end of therapy.
- Patients must have measurable disease as defined by RECIST criteria (Therasse et al. 2000):
- Have adequate organ function including the following
- EXCLUSION:
- 1\. Have serious concomitant systemic disorders (eg, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00191347
Start Date
October 1 2004
End Date
November 1 2005
Last Update
January 26 2007
Active Locations (1)
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1
For additional information regarding investigative sites for thsi trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ottawa, Ontario, Canada