Back to resultsTemozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer (Study P03247)
Primary Purpose
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Brain Neoplasms
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Temozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung
Eligibility 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)
Sites / Locations
Outcomes
Primary Outcome Measures
Overall Survival
Secondary Outcome Measures
Time to radiological CNS progression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00076856
Brief Title
Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer (Study P03247)
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 31, 2004 (Actual)
Primary Completion Date
March 31, 2006 (Actual)
Study Completion Date
March 31, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Brain Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Primary Outcome Measure Information:
Title
Overall Survival
Secondary Outcome Measure Information:
Title
Time to radiological CNS progression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
12. IPD Sharing Statement
Citations:
PubMed Identifier
20439193
Citation
Chua D, Krzakowski M, Chouaid C, Pallotta MG, Martinez JI, Gottfried M, Curran W, Throuvalas N. Whole-brain radiation therapy plus concomitant temozolomide for the treatment of brain metastases from non-small-cell lung cancer: a randomized, open-label phase II study. Clin Lung Cancer. 2010 May;11(3):176-81. doi: 10.3816/CLC.2010.n.022.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis Links
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer (Study P03247)
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