A Phase II Study of Biweekly Pemetrexed and Gemcitabine in Patients With Metastatic Breast Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
A Phase II Study of Biweekly Pemetrexed and Gemcitabine in Patients With Metastatic Breast Cancer
Inclusion Criteria
INCLUSION:
1. Have a performance status of 0 to 2 on the ECOG performance status schedule.
2. 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.
3. Patients must have measurable disease as defined by RECIST criteria (Therasse et al.
2000):
4. 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.
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
Outcome Measure:
To determine the objective tumor response rate for pemetrexed plus gemcitabine administered every 14 days, in patients with MBC who have received up to one prior chemotherapy for metastatic disease(not including prior adjuvant chemotherapy)
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours,EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
Canada: Health Canada
Study ID:
9305
NCT ID:
NCT00191347
Start Date:
October 2004
Completion Date:
November 2005
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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