A Phase II Multicenter Study Of Lometrexol Sodium And Folic Acid In Subjects With Previously Treated Stage IIIB or IV Non-Small Cell Lung Cancer
- Determine the overall response rate in patients with previously treated stage IIIB or
IV non-small cell lung cancer when treated with lometrexol and folic acid.
- Determine the complete response rate, duration of response, and time to progression in
patients treated with this regimen.
- Determine the 1-year survival rate and overall survival in patients treated with this
- Determine the safety profile of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral folic acid once daily on days -7 to 6. Patients also receive
lometrexol IV over 30-60 seconds on day 1. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity.
Patients are followed up to 2 months after removal from study and then every 3 months
PROJECTED ACCRUAL: A total of 50-100 patients will be accrued for this study.
Primary Purpose: Treatment
United States: Federal Government
|UCSF Cancer Center and Cancer Research Institute||San Francisco, California 94115-0128|
|Louisiana State University School of Medicine||New Orleans, Louisiana 70112-2822|
|U.S. Oncology Research Inc.||Houston, Texas 77060|
|Tyler Cancer Center||Tyler, Texas 75702|
|Cancer Care Northwest||Spokane, Washington 99202|
|Cancer Centers of Florida (U.S. Oncology)||Orlando, Florida 32806|
|US Oncology - Albany Regional Cancer Center||Albany, New York 12208|