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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00034697
First received: May 1, 2002
Last updated: May 31, 2006
Last verified: May 2006
History of Changes
  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 2

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:

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
Obsolete Identifiers: NCT00030836
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 May 23, 2013