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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 completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: May 1, 2002
Last updated: April 24, 2014
Last verified: April 2014

May 1, 2002
April 24, 2014
June 2001
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Complete list of historical versions of study NCT00034697 on Archive Site
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Study of Temozolomide in the Treatment of Brain Metastasis From Non-small-cell Lung Cancer (Study P02143)
A Phase II Study of Temozolomide (SCH 52365) in Subjects With Brain Metastasis From Non-Small-Cell Lung Cancer

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.

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Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Metastases, Neoplasm
  • Carcinoma, Non-Small-Cell Lung
  • Brain Neoplasms
Drug: temozolomide
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2003
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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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
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Merck Sharp & Dohme Corp.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP