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.

Condition	Treatment or Intervention	Phase
stage IV non-small cell lung cancer stage IIIB non-small cell lung cancer recurrent non-small cell lung cancer Quality of Life	Drug: -propargyl-10-deazaaminopterin	Phase II

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed stage IIIB (pleural or pericardial disease) or stage IV non-small cell lung cancer
• Measurable or evaluable indicator lesion that has not been irradiated; Pleural effusions, bone metastases, brain metastases, elevated serum enzymes, and abnormal radionucliotide scans are unacceptable as sole indicator lesions
• No clinically significant pleural effusions or ascites
• No grade III or IV edema
• No prior pneumonectomy
• No symptomatic or uncontrolled brain or leptomeningeal involvement

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy OR Progression after stable disease or initial response to 1 prior chemotherapy regimen, including 1 preoperative or adjuvant chemotherapy regimen
• Endocrine therapy: Concurrent steroids allowed if dose is stable
• Radiotherapy: See Disease Characteristics; At least 3 weeks since prior radiotherapy
• Surgery: See Disease Characteristics
• Other: No prior antifolates; At least 7 days since prior folic acid supplements

--Patient Characteristics--

• Age: 18 and over
• Performance status: Karnofsky 70-100%
• Life expectancy: Not specified
• Hematopoietic: WBC at least 4,000/mm3; Hemoglobin at least 10 g/dL; Platelet count at least 160,000/mm3
• Hepatic: Bilirubin no greater than 1.0 mg/dL; AST no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 5 times ULN
• Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min
• Cardiovascular: No unstable cardiac disease requiring treatment
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No other concurrent active cancer; No history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures; No active uncontrolled infection; No other serious illness or medical condition

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Lee M. Krug,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000067482; MSKCC-99053; NCI-H99-0045
Record last reviewed:  April 2004
Record first received:  January 28, 2000
ClinicalTrials.gov Identifier:  NCT00004238
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-25