Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Published Results
Trial Contact Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI MSKCC-99053 NCI-H99-0045

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.

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

Projected Accrual

A total of 19-39 patients will be accrued for this study within 12 months.

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.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Krug LM, Azzoli CG, Kris MG, et al.: 10-propargyl-10-deazaaminopterin: an antifolate with activity in patients with previously treated non-small cell lung cancer. Clin Cancer Res 9 (6): 2072-8, 2003.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Lee Krug, MD, Protocol chair		Ph: 212-639-8420

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