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



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

For Condition: stage 4 non-small cell lung cancer,recurrent non-small cell lung cancer,stage 3B non-small cell lung cancer,Quality of Life
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
LeeKrug,  Study Chair,  Memorial Sloan-Kettering Cancer Center

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


Additional Information:
Study ID Numbers:
  CDR0000067482;  MSKCC-99053,NCI-H99-0045
Study Start Date: July 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004238

Other Quality Of Life Studies:
1. Arsenic Trioxide in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

2. Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

3. Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2

4. Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer

5. Suramin, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

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