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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00076856
• Other study ID #: P03247
• Status: Completed
• Phase: Phase 2
• First received: February 4, 2004
• Last updated: May 8, 2017
• Start date: March 31, 2004
• Est. completion date: March 31, 2006

Study information

• Verified date: May 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: March 31, 2006
• Est. primary completion date: March 31, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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)

Related Conditions & MeSH terms

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

Intervention

Drug:
• Temozolomide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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 pha — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival
Secondary	Time to radiological CNS progression