Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer (Study P03247AM3)(COMPLETED)

This study has been completed.

First Received: February 4, 2004 Last Updated: March 1, 2007 History of Changes

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00076856

Purpose

The purpose of this study is to demonstrate improvement in overall survival for the combination of whole brain radiation therapy (WBRT) plus temozolomide (TMZ) versus WBRT alone. Secondary objective is to demonstrate an improvement in the time to radiological CNS progression with the addition of TMZ to WBRT.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis Brain Neoplasms	Drug: Temozolomide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Open-Label Phase 2 Study of Temozolomide Added to Whole Brain Radiation Therapy Versus Whole Brain Radiation Therapy Alone for the Treatment of Brain Metastasis From Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Lung Cancer

Drug Information available for: Temozolomide

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Overall Survival

Secondary Outcome Measures:

Time to radiological CNS progression

Estimated Enrollment:	100
Study Start Date:	March 2004
Estimated Study Completion Date:	November 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Age greater than or equal to 18
Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC)
At least one brain metastasis diagnosed within 30 days of randomization
Brain metastases must not have been previously treated with WBRT or radiosurgery
No more than 2 sites of extracranial metastases
May have received prior radiation therapy to the primary tumor and/or systemic metastatic sites
Meets protocol requirements for specified laboratory values.
Written informed consent and cooperation of patient
Appropriate use of effective contraception if of childbearing potential.
Karnofsky Performance Status KPS greater than 70
Score less than 2 on all criteria of the Comprehensive Neurological Outcome Scale (CNOS)

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	P03247
Study First Received:	February 4, 2004
Last Updated:	March 1, 2007
ClinicalTrials.gov Identifier:	NCT00076856 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Central Nervous System Neoplasms
Brain Diseases
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Neoplasm Metastasis
Alkylating Agents
Nervous System Neoplasms

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Central Nervous System Diseases
Temozolomide
Pharmacologic Actions
Carcinoma
Brain Neoplasms
Neoplasms
Lung Diseases
Antineoplastic Agents, Alkylating
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009