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Study of Temozolomide in the Treatment of Brain Metastasis From Non-small-cell Lung Cancer (Study P02143)

This study has been terminated.
(Slow Enrollment)
ClinicalTrials.gov Identifier:
First Posted: May 2, 2002
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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:

Further study details as provided by Merck Sharp & Dohme Corp.:

Enrollment: 24
Actual Study Start Date: June 28, 2001
Study Completion Date: January 30, 2003
Primary Completion Date: January 30, 2003 (Final data collection date for primary outcome measure)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 Data/Documents: CSR Synopsis Links  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00034697     History of Changes
Obsolete Identifiers: NCT00030836
Other Study ID Numbers: P02143
First Submitted: May 1, 2002
First Posted: May 2, 2002
Last Update Posted: May 23, 2017
Last Verified: May 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Brain mets
non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Brain Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents