A Phase II Study of TEMOZOLOMIDE in Advanced Non-Small Cell Lung Cancer With and Without Brain Metastases
OBJECTIVES: I. Assess the therapeutic activity of temozolomide (TMZ) in patients with
non-small cell lung cancer (NSCLC) with or without brain metastases, untreated by
chemotherapy for metastatic disease. II. Characterize the acute side effects of temozolomide
in these patients. III. Assess the duration of response in responding patients.
OUTLINE: This is an open label, nonrandomized, multicenter study. Temozolomide is given by
oral doses that are equally fractionated over 5 days and repeated every 4 weeks. Patients
with brain metastases: Treatment is discontinued if there is progression of disease in both
sites (brain and nonbrain) or if there is progression of disease of the brain lesion and
stable disease of the other target lesions. Patients with progressive disease of the brain
target lesions with contemporary evidence of response in the other target lesion can receive
further temozolomide, in addition to nonchemotherapy medical treatment of the brain
metastases (steroids, mannitol, etc.). Patients with progressive disease in the other target
lesions with contemporary evidence of response of the brain target lesions can receive
further temozolomide therapy, in addition to specific local radiotherapy of the nonbrain
lesions. Patients without brain metastases: Treatment discontinues if there is clear cut
progression occurring before the first disease evaluation (8 weeks after treatment start).
For stable disease, the patient is treated for a minimum of 8 weeks and evaluated
thereafter. Treatment, in most cases, is for a minimum of 2 cycles and may continue for a
maximum of 6 cycles in the absence of disease progression, unacceptable toxicity, or patient
refusal. All patients are followed every 6 weeks for survival.
PROJECTED ACCRUAL: A minimum of 24 evaluable patients and a maximum of 70 evaluable patients
will be accrued for this study.
Primary Purpose: Treatment
Giuseppe Giaccone, MD, PhD
Free University Medical Center
United States: Federal Government