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


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastases, Neoplasm, Carcinoma, Non-Small-Cell Lung, Brain Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

P02143

NCT ID:

NCT00034697

Start Date:

June 2001

Completion Date:

November 2003

Related Keywords:

  • Metastases, Neoplasm
  • Carcinoma, Non-Small-Cell Lung
  • Brain Neoplasms
  • Brain mets
  • non-small cell lung cancer
  • Brain Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis

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