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Home > "S" Clinical Trials Conditions > Study of Temozolomide in the Treatment of Brain Metastasis from Non-small-cell Lung Cancer  Study of Temozolomide in the Treatment of Brain Metastasis from Non-small-cell Lung Cancer
Study of Temozolomide in the Treatment of Brain Metastasis from Non-small-cell Lung Cancer
For Condition: Brain Neoplasms,Carcinoma, Non-Small-Cell Lung,Metastases, Neoplasm
Status: Completed
Sponsor(s): Schering-Plough ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 60
Location and Contact Information:
Christie Hospital
Manchester, , M204BX
United Kingdom
University of Colorado Cancer Center
Denver, Colorado, 80220-3706
United States
Anschutz Cancer Pavilion
Aurora, Colorado,
United States
Additional Information:
Study ID Numbers: P02143;
Study Start Date: June 2001
Record last reviewed: July 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034697
Other Metastases, Neoplasm Studies:
1. Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole
2. This study is to assess the efficacy and safety of ZD6474 in subjects with Non-small cell lung cancer.
3. A Phase 3 Randomized Study of Lonafarnib in Combination With Paclitaxel and Carboplatin vs. Placebo in Combination with Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer
4. A Phase 2 Trial of ALIMTA (pemetrexed) in Locally Advanced or Metastatic Recurrent Transitional Cell Carcinoma of the Urothelium
5. Study of 111In-DAC as an Medical Imaging Agent for Lung Cancer and Brain Cancer Consistent with Metastatic Lung Cancer
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Study of Temozolomide in the Treatment of Brain Metastasis from Non-small-cell Lung Cancer
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