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

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

A Phase II Study of 10-Propargyl-10-Deazaaminopterin (PDX) in Patients With Advanced 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

Inclusion 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

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Lee M. Krug, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 1999

Completion Date:

June 2002

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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