Temozolomide for Treatment of Brain Metastases From Non-S... | NCT00076856

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

NCT00076856

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

May 9, 2017Actual

Enrollment

95Actual

Phase

Phase 2

Conditions

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

Interventions

Temozolomide

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 31, 2004Actual

Primary Completion Date

Mar 31, 2006Actual

Completion Date

Mar 31, 2006Actual

First Submitted Date

Feb 4, 2004

First Submission Date that Met QC Criteria

Feb 5, 2004

First Posted Date

Feb 6, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2017

Last Update Posted Date

May 9, 2017Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

95Actual

Name	Type	Description	Arm Group Labels	Other Names
Temozolomide	Drug

Measure	Description	Time Frame
Overall Survival

Measure	Description	Time Frame
Time to radiological CNS progression

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20439193	Result	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.

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

ID	Term
D003606	Dacarbazine
D014226	Triazenes
D009930	Organic Chemicals
D007093	Imidazoles

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D009362	Neoplasm Metastasis
D001932	Brain Neoplasms