NCT00003062

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2002

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

February 16, 2004

Completed
Last Updated

July 2, 2012

Status Verified

June 1, 2012

Enrollment Period

4.5 years

First QC Date

November 1, 1999

Last Update Submit

June 29, 2012

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage IV non-small cell lung cancer

Interventions

temozolomideDRUG

Eligibility Criteria

AgeUp to 69 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Istituto Nazionale per la Ricerca sul Cancro

Genoa, 16132, Italy

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1001HV, Netherlands

Location

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

Medical Oncology Centre of Rosebank

Johannesburg, 2193, South Africa

Location

Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Related Publications (1)

  • Dziadziuszko R, Ardizzoni A, Postmus PE, Smit EF, Price A, Debruyne C, Legrand C, Giaccone G; EORTC Lung Cancer Group. Temozolomide in patients with advanced non-small cell lung cancer with and without brain metastases. a phase II study of the EORTC Lung Cancer Group (08965). Eur J Cancer. 2003 Jun;39(9):1271-6. doi: 10.1016/s0959-8049(03)00234-x.

    PMID: 12763216RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Giuseppe Giaccone, MD, PhD

    Free University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

February 16, 2004

Study Start

July 1, 1997

Primary Completion

January 1, 2002

Last Updated

July 2, 2012

Record last verified: 2012-06

Locations

IT(1)GB(1)NL(1)PL(1)ZA(1)