Clinical Trial: Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer
Brief Summary: The purposes of this study are to determine whether pemetrexed can help patients with metastatic (cancer that has spread to other parts of the body) breast cancer, to determine any side effects that may be associated with the drug, to determine how much pemetrexed should be given to patients, and to collect DNA for future research regarding metastatic breast cancer. The collection of DNA is optional to the patient.
Detailed Summary:
Sponsor: Eli Lilly and Company
Current Primary Outcome: Overall Tumor Response [ Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression ]
Original Primary Outcome:
Current Secondary Outcome:
- Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) [ Time Frame: every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up ]
- Duration of Tumor Response [ Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression ]
- Progression-Free Survival Time [ Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression ]
- Overall Survival Time [ Time Frame: every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up ]
Original Secondary Outcome:
Information By: Eli Lilly and Company
Dates:
Date Received: March 18, 2005
Date Started: April 2005
Date Completion:
Last Updated: May 29, 2009
Last Verified: April 2009
