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

NCT00076856 | Completed Phase 2

• 1 other identifier: P03247
• Study Type: interventional
• Target: 95
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Brain Neoplasms

Outcome Measures

Primary Outcomes (1)

• Overall Survival

Secondary Outcomes (1)

• Time to radiological CNS progression

Interventions

Temozolomide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 20439193 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Brain Neoplasms

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2004
• First Posted: February 6, 2004
• Study Start: March 31, 2004
• Primary Completion: March 31, 2006
• Study Completion: March 31, 2006
• Last Updated: May 9, 2017

Record last verified: 2017-05