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

This study has been completed.

First Received on May 1, 2002. Last Updated on May 31, 2006 History of Changes

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00034697

Purpose

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.

Condition	Intervention	Phase
Metastases, Neoplasm Carcinoma, Non-Small-Cell Lung Brain Neoplasms	Drug: temozolomide	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Phase II Study of Temozolomide (SCH 52365) in Subjects With Brain Metastasis From Non-Small-Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Lung Cancer

Drug Information available for: Temozolomide

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Estimated Enrollment:	60
Study Start Date:	June 2001
Estimated Study Completion Date:	November 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00034697 History of Changes
Other Study ID Numbers:	P02143
Study First Received:	May 1, 2002
Last Updated:	May 31, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

Brain mets
non-small cell lung cancer

Additional relevant MeSH terms:

Brain Neoplasms
Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic

Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012