Lometrexol Plus Folic Acid in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Recruitment status was Active, not recruiting
RATIONALE: Lometrexol may stop or slow the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Folic acid may be effective in preventing or lessening the side effects of lometrexol. Combining lometrexol with folic acid may be an effective treatment for non-small cell lung cancer.
PURPOSE: Phase II trial to study the effectiveness of combining lometrexol with folic acid in treating patients who have stage IIIB or stage IV non-small cell lung cancer that has been previously treated.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||February 2002|
- 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.
|United States, California|
|UCSF Cancer Center and Cancer Research Institute|
|San Francisco, California, United States, 94143-0128|
|United States, Florida|
|Cancer Centers of Florida (U.S. Oncology)|
|Orlando, Florida, United States, 32806|
|United States, Louisiana|
|Louisiana State University School of Medicine|
|New Orleans, Louisiana, United States, 70112-2822|
|United States, New York|
|US Oncology - Albany Regional Cancer Center|
|Albany, New York, United States, 12208|
|United States, Texas|
|U.S. Oncology Research Inc.|
|Houston, Texas, United States, 77060|
|Tyler Cancer Center|
|Tyler, Texas, United States, 75702|
|United States, Washington|
|Cancer Care Northwest|
|Spokane, Washington, United States, 99202|
|Study Chair:||David Tesarowski||Tularik|