Lung Cancer Clinical Trial
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
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.
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.
;
Primary Purpose: Treatment
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