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Temozolomide in the Treatment of Advanced Non-Small Cell Lung Carcinoma: Phase II Evaluation in Previously Treated and Chemo-Naive Patients
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 temozolomide in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.
OBJECTIVES: I. Determine the objective response rate to temozolomide in previously treated (closed to accrual 8/01) and chemotherapy-naive patients with advanced non-small cell lung cancer. II. Determine the freedom from progression median, and 1-year and 2-year survival rates in these patients on this regimen. OUTLINE: Patients are stratified by prior chemotherapy (yes (closed to accrual 8/01) vs no). Patients receive oral temozolomide daily for 42 days. Treatment repeats every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: Up to 66 patients (33 per stratum (previously treated stratum closed to accrual 8/01)) will be accrued for this study within 2 years.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Start Date
January 1, 2000
Primary Completion Date
October 1, 2002
Completion Date
April 1, 2008
Last Updated
May 6, 2014
51
ACTUAL participants
temozolomide
DRUG
Temozolomide
DRUG
Lead Sponsor
Fox Chase Cancer Center
Collaborators
NCT06498635
NCT06066138
Data Source & Attribution
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