Lung Cancer Clinical Trial
Official title:
A Phase II Study of 10-Propargyl-10-Deazaaminopterin (PDX) in Patients With Advanced Non-Small Cell Lung Cancer
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.
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.
;
Primary Purpose: Treatment
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