Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer (Study P03247)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: February 4, 2004
Last updated: April 30, 2015
Last verified: April 2015
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Overall Survival

Secondary Outcome Measures:
  • Time to radiological CNS progression

Enrollment: 95
Study Start Date: March 2004
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  • 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)
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No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00076856     History of Changes
Other Study ID Numbers: P03247 
Study First Received: February 4, 2004
Last Updated: April 30, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Brain Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Brain Diseases
Bronchial Neoplasms
Carcinoma, Bronchogenic
Central Nervous System Diseases
Central Nervous System Neoplasms
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Neoplastic Processes
Nervous System Diseases
Nervous System Neoplasms
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 04, 2016