NCT00006007

LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer

A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining LY231514 plus gemcitabine in treating women who have metastatic breast cancer.

Detailed description

OBJECTIVES: * Assess the antitumor activity of pemetrexed disodium in combination with gemcitabine in the treatment of women with metastatic breast cancer who have received an anthracycline and a taxane in the adjuvant and/or metastatic setting and no more than 1 chemotherapy regimen for metastatic disease (unless these were a taxane and anthracycline). * Determine the toxicity of this regimen in this patient population. * Determine time to progression and overall survival of these patients receiving this regimen. OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8. pemetrexed disodium IV is administered over 10 minutes 90 minutes following gemcitabine on day 8. Treatment continues every 21 days for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients achieving a complete response receive 2 additional courses. Patients are followed every 3 months for 5 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1 year.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride
DRUG	pemetrexed disodium

Timeline

• Start date: 2000-12-01
• Primary completion: 2004-03-01
• Completion: 2008-05-01
• First posted: 2003-01-27
• Last updated: 2016-12-07

Locations

24 sites across 2 countries: United States, Canada