Lung Cancer Clinical Trial
Lometrexol Plus Folic Acid in Treating Patients With Stage IIIB or Stage 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.
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.
Histologically confirmed non-small cell lung cancer (NSCLC)
Stage IIIB or IV
Squamous cell carcinoma
Large cell carcinoma
Progressive disease after receiving 1 cisplatin- or carboplatin-containing regimen for stage IIIB or IV disease
At least 1 lesion at least 1 cm x 1 cm by CT scan either not in a previously irradiated field or showing clear evidence of disease progression after radiation
No symptomatic or rapidly increasing, moderate or large amounts of pleural effusion or ascites
No prior or concurrent CNS metastases (brain or meningeal)
18 and over
At least 3 months
Absolute neutrophil count at least 1,500/mm^3*
Platelet count at least 100,000/mm^3*
Hemoglobin at least 9.0 g/dL*
*Without transfusions or growth factors in the previous 7 days
Bilirubin no greater than 1.5 times upper limit of normal (ULN) (regardless of liver involvement secondary to tumor)
AST and ALT no greater than 2.5 times ULN (5 times ULN if liver has tumor involvement)
Calculated creatinine clearance at least 60 mL/min using Cockroft and Gault formula
No inflammatory bowel disease
No radiation enteritis
No malabsorption syndrome
No inability to absorb folic acid
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during study
No known untreated vitamin B12 deficiency
No drug abusers
No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
No severe concurrent disease or major comorbidity that would preclude study participation
PRIOR CONCURRENT THERAPY:
At least 3 weeks since prior biologic therapy for NSCLC and recovered from acute side effects
Prior treatment with an experimental vaccine allowed
No concurrent routine or prophylactic filgrastim (G-CSF), sargramostim (GM- CSF), or epoetin alfa
See Disease Characteristics
At least 3 weeks since prior chemotherapy for NSCLC (6 weeks for mitomycin or nitrosourea) and recovered from acute side effects
Prior adjuvant or neoadjuvant chemotherapy allowed
See Disease Characteristics
Recovered from acute side effects of prior radiotherapy
No prior radiotherapy to 25% or more of bone marrow
No prior whole pelvic irradiation
At least 3 weeks since prior major surgery and recovered
At least 3 weeks since prior investigational agent
No concurrent proguanil, trimethoprim, co-trimoxazole, or pyrimethamine
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There are 7 Locations for this study
San Francisco California, 94143, United States
Orlando Florida, 32806, United States
New Orleans Louisiana, 70112, United States
Albany New York, 12208, United States
Houston Texas, 77060, United States
Tyler Texas, 75702, United States
Spokane Washington, 99202, United States
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