Phase II Study of 10-Propargyl-10-Deazaaminopterin in Patients With Advanced Non-Small Cell Lung Cancer (Summary Last Modified 09/2001)
Last Modified: 6/11/2004 First Published: 2/1/2000
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. Published ResultsKrug 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 | | | |
|