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

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

This study has been completed.

Sponsored by:	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

MedlinePlus related topics:

Brain Cancer Cancer Lung Cancer

ChemIDplus related topics:

Temozolomide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase II Study of Temozolomide (SCH 52365) in Subjects With Brain Metastasis From Non-Small-Cell Lung Cancer

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

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

Keywords provided by Schering-Plough:

Brain mets

non-small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms

Non-small cell lung cancer

Central Nervous System Diseases

Central Nervous System Neoplasms

Brain Diseases

Temozolomide

Carcinoma

Brain Neoplasms

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Neoplasm Metastasis

Carcinoma, Non-Small-Cell Lung

Nervous System Neoplasms

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Nervous System Diseases

Pharmacologic Actions

Neoplasms

Neoplastic Processes

Neoplasms by Site

Pathologic Processes

Therapeutic Uses

Antineoplastic Agents, Alkylating

Alkylating Agents

ClinicalTrials.gov processed this record on October 07, 2008