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Temozolomide in Patients With Progressive or Recurrent Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00003062
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : July 2, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: temozolomide Phase 2

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 69 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003062

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
South Africa
Medical Oncology Centre of Rosebank
Johannesburg, South Africa, 2193
United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Giuseppe Giaccone, MD, PhD Free University Medical Center
More Information

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00003062     History of Changes
Other Study ID Numbers: EORTC-08965
First Posted: February 16, 2004    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
recurrent non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents