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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00076856
First Posted: February 6, 2004
Last Update Posted: May 9, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date: March 31, 2004
Study Completion Date: March 31, 2006
Primary Completion Date: March 31, 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Publications:
Study Data/Documents: CSR Synopsis Links  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00076856     History of Changes
Other Study ID Numbers: P03247
First Submitted: February 4, 2004
First Posted: February 6, 2004
Last Update Posted: May 9, 2017
Last Verified: May 2017

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