A Study of Biweekly Pemetrexed and Gemcitabine in Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191347
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007

September 12, 2005
January 24, 2007
October 2004
Not Provided
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)
To detemine 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)
Complete list of historical versions of study NCT00191347 on ClinicalTrials.gov Archive Site
To measure time-to-event efficacy variables including: time to objective tumor response for responding patients, duration of response for responding pts, time to treatment failure, time to progressive disease, progression free survival, overall survival
Same as current
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A Study of Biweekly Pemetrexed and Gemcitabine in Patients With Metastatic Breast Cancer
A Phase II Study of Biweekly Pemetrexed and Gemcitabine in Patients With Metastatic Breast Cancer

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 activity in patients with locally advanced or metastatic breast cancer. In addition, in the phase I combination trial of the two agents, a durable tumor response was seen in one out of three heavily pretreated breast cancer patients (Adjei et al. 2000). Therefore, it is reasonable to expect that the combination of pemetrexed and gemcitabine administered may be associated with considerably more anti-tumor activity than either agent alone. If such activity is seen in this study, randomized studies comparing this combination with other active agents or combinations of active agents will be considered.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: pemetrexed
  • Drug: gemcitabine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2005
Not Provided

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.

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00191347
9305, H3E-CA-S050
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP