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
OBJECTIVES:
- 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
regimen.
- 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
thereafter.
PROJECTED ACCRUAL: A total of 50-100 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
David Tesarowski
Study Chair
Tularik
United States: Federal Government
CDR0000069316
NCT00033722
February 2002
Name | Location |
---|---|
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 |