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A Phase II Study of TEMOZOLOMIDE in Advanced Non-Small Cell Lung Cancer With and Without Brain Metastases

Phase 2
69 Years
Not Enrolling
Lung Cancer

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Trial Information

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed progressive or recurrent stage IV
non-small cell lung cancer (NSCLC) Patient with brain metastases on CT or MRI scan are
included Symptomatic cases must have had brain radiotherapy at least one month prior to
registration Patients without brain metastases: At least one target lesion Bidimensionally
measurable Not previously irradiated

PATIENT CHARACTERISTICS: Age: Under 70 Performance status: WHO 0-2 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count greater than 2,000/mm3 WBC greater than
3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.46
mg/dL Transaminases less than 2 times upper limit of normal Renal: Creatinine no greater
than 1.70 mg/dL Creatinine clearance greater than 60 mL/min Other: No prior or concurrent
malignancies at other sites with the exception of adequately treated in situ carcinoma of
the cervix or basal and squamous carcinoma of the skin Not pregnant or nursing Negative
pregnancy test 24 hours prior to commencing temozolomide

PRIOR CONCURRENT THERAPY: No other investigational drugs allowed during this study
Biologic therapy: Prior biologic therapy allowed No concurrent biologic therapy allowed No
concurrent growth factor to induce neutrophil increase No concurrent erythropoietin
Chemotherapy: No prior chemotherapy for metastatic disease At least 3 months since any
neoadjuvant and adjuvant treatment, and induction chemotherapy preceding radical
radiotherapy Endocrine therapy: See Protocol Outline Concurrent steroids should be
maintained on the lowest dose possible Radiotherapy: Prior radiotherapy allowed Concurrent
local radiotherapy to nonbrain lesions allowed Concurrent palliative radiation therapy of
bone lesions permitted No concurrent radiation to target lesions No concurrent brain
radiotherapy Surgery: Prior surgery allowed

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Giuseppe Giaccone, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Free University Medical Center


United States: Federal Government

Study ID:




Start Date:

July 1997

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms