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Phase II Trial of Alimta (Pemetrexed) and Gemzar (Gemcitabine) in Metastatic Breast Cancer Patients Who Have Received Prior Taxane Therapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Breast Neoplasms

Thank you

Trial Information

Phase II Trial of Alimta (Pemetrexed) and Gemzar (Gemcitabine) in Metastatic Breast Cancer Patients Who Have Received Prior Taxane Therapy


Inclusion Criteria:



- Must have received prior chemotherapy with Taxol (paclitaxel) or Taxotere
(docetaxel).

- Less than 3 different chemotherapy treatments for metastatic disease.

- Prior treatment with hormonal and/or radiation therapy.

- Must have disease that can be measured.

- Must be able to take care of self needs for example personal hygiene

Exclusion Criteria:

- Must not be pregnant or breast-feeding.

- Cancer that has spread to the brain.

- Treatment with Gemcitabine or Pemetrexed

- Unable to take folic acid or Vitamin B12

- Treatment for another cancer within the last 5 years

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:

Overall Tumor Response

Outcome Time Frame:

Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

5141

NCT ID:

NCT00063570

Start Date:

July 2003

Completion Date:

January 2008

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms
  • Cancer of Breast
  • Cancer of the Breast
  • Breast Neoplasms
  • Neoplasms

Name

Location
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. Lakeland, Florida  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. Aurora, Colorado  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. Morrisville, North Carolina  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. Philadelphia, Pennsylvania  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. Dallas, Texas  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician. Seattle, Washington