Study of Temozolomide in the Treatment of Brain Metastasis From Non-Small-Cell Lung Cancer (Study P02143)(COMPLETED) - Tabular View

Tracking Information
First Received Date ^ICMJE	May 1, 2002
Last Updated Date	May 31, 2006
Start Date ^ICMJE	June 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00034697 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Temozolomide in the Treatment of Brain Metastasis From Non-Small-Cell Lung Cancer (Study P02143)(COMPLETED)
Official Title ^ICMJE	A Phase II Study of Temozolomide (SCH 52365) in Subjects With Brain Metastasis From Non-Small-Cell Lung Cancer
Brief Summary	Brain metastases from solid tumors are diagnosed in more than 300,000 patients annually. Nonsmall cell lung cancer accounts for the majority of CNS mets. Treatment with whole brain radiation and steroids will improve neurologic symptoms in about 50% of patients although survival is short. This study will test the safety and efficacy of temozolomide in combination with radiation therapy in the treatment of patients with brain mets form nonsmall cell lung cancer.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Metastases, Neoplasm Carcinoma, Non-Small-Cell Lung Brain Neoplasms
Intervention ^ICMJE	Drug: temozolomide
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	November 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Histologic confirmation of non-small-cell lung cancer Stable systemic disease Maximum of one prior chemotherapy regimen for metastatic systemic disease Radiotherapy for local control or palliative bony lesions is allowed Karnofsky of greater than or equal to 70% Adequate hematologic, renal and liver function Exclusion Criteria: Patients eligible for surgery of the brain Any previous chemotherapy for the brain metastasis Chemotherapy within 4 weeks or previous temozolomide Prior radiotherapy to the brain Radiation therapy to greater than 50% of the bone marrow Insufficient recovery from previous therapies Active nonmalignant systemic disease Inability to take oral medication Pregnant or nursing women Non use of adequate contraceptive techniques, negative urine pregnancy test is required Known AIDS related illness
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00034697
Responsible Party
Study ID Numbers ^ICMJE	P02143
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	May 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP