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
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:
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.
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer (NSCLC)
Stage IIIB or IV
Progressive disease after receiving 1 cisplatin- or carboplatin-containing regimen for stage IIIB or IV disease
Measurable disease
No symptomatic or rapidly increasing, moderate or large amounts of pleural effusion or ascites
No prior or concurrent CNS metastases (brain or meningeal)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other: