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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00076856
First received: February 4, 2004
Last updated: May 15, 2014
Last verified: May 2014
  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
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)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
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: May 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Neoplasms
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
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014