Temozolomide in Patients With Progressive or Recurrent Non-small Cell Lung Cancer
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 effect of temozolomide in patients with progressive or recurrent stage IV non-small cell lung cancer, with or without brain metastases, who have not been treated for metastatic disease with chemotherapy.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of TEMOZOLOMIDE in Advanced Non-Small Cell Lung Cancer With and Without Brain Metastases|
|Study Start Date:||July 1997|
|Primary Completion Date:||January 2002 (Final data collection date for primary outcome measure)|
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.
|Istituto Nazionale per la Ricerca sul Cancro|
|Genoa, Italy, 16132|
|Vrije Universiteit Medisch Centrum|
|Amsterdam, Netherlands, 1001HV|
|Medical University of Gdansk|
|Gdansk, Poland, 80-211|
|Medical Oncology Centre of Rosebank|
|Johannesburg, South Africa, 2193|
|Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|Study Chair:||Giuseppe Giaccone, MD, PhD||Free University Medical Center|