Spots Global Cancer Trial Database for 10-Propargyl-10-Deazaaminopterin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

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Trial Identification

Brief Title: 10-Propargyl-10-Deazaaminopterin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Official Title: A Phase II Study of 10-Propargyl-10-Deazaaminopterin (PDX) in Patients With Advanced Non-Small Cell Lung Cancer

Study ID: NCT00004238

Conditions

Lung Cancer

Interventions

pralatrexate

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of 10-propargyl-10-deazaaminopterin in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Detailed Description: OBJECTIVES: I. Determine objective response rate, duration of response, and time to disease progression in patients with stage IIIB (pleural or pericardial disease) or stage IV non-small cell lung cancer treated with 10-propargyl-10-deazaaminopterin as first line or second line chemotherapy. II. Determine the toxicity of this drug in this patient population. III. Determine duration of survival in these patients. IV. Determine quality of life of these patients. OUTLINE: Patients receive 10-propargyl-10-deazaaminopterin IV on days 1 and 15. Treatment repeats every 4 weeks in the absence of unacceptable toxicity or disease progression. Quality of life is assessed at the beginning of each course. Patients are followed every 8 weeks for disease progression. PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study within 12 months.