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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.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00034697
First received: May 1, 2002
Last updated: January 28, 2015
Last verified: January 2015

May 1, 2002
January 28, 2015
June 2001
January 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00034697 on ClinicalTrials.gov 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.
Not Provided
Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2003
January 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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United Kingdom,   United States
 
NCT00034697
P02143
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
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Merck Sharp & Dohme Corp.
January 2015

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