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Temozolomide and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastasis Secondary to Non-Small Cell Lung Cancer



Temozolomide and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastasis Secondary to Non-Small Cell Lung Cancer

For Condition: Non-small cell lung cancer,brain metastases
Status: Not yet recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as temozolomide may make the tumor cells more sensitive to radiation therapy. Combining temozolomide with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with whole-brain radiation therapy in treating patients who have brain metastasissecondary to non-small cell lung cancer.
Details: OBJECTIVES: Primary - Determine the intracranial response rate in patients with brain metastasis secondary to non-small cell lung cancer treated with whole brain radiotherapy and temozolomide. Secondary - Determine the time to radiological progression in patients treated with this regimen. - Determine the time to neurological progression (confirmed by MRI) in patients treated with this regimen. - Determine the overall survival of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients undergo whole brain radiotherapy once daily, 5 days a week, for 2 weeks (10 fractions). Patients also receive concurrent oral temozolomide once daily on days 1-14. Beginning 3 weeks after the completion of chemoradiotherapy, patients receive oral temzolomide once daily on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of CNS progression or unacceptable toxicity. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer (NSCLC), including the following histologies: - Squamous cell carcinoma - Adenocarcinoma - Large cell carcinoma - Bronchoalveolar carcinoma - All variants of NSCLC - Bidimensionally or unidimensionally measurable brain metastasis - Confirmed by MRI within the past two weeks - CT scan is not acceptable - Biopsy is not required - Not eligible for surgical resection or radiosurgery of brain metastasis - Systemic disease not in immediate need of chemotherapy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - More than 12 weeks Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 - Hemoglobin 10 g/dL Hepatic - Bilirubin 2 times upper limit of normal (ULN) - AST and ALT 2 times upper limit of normal (5 times ULN if liver metastases are present) - Alkaline phosphatase 2 times ULN (5 times ULN if liver metastases are present) Renal - Creatinine 1.6 mg/dL Other - HIV negative - No AIDS-related illness - No poor medical risks due to active nonmalignant systemic disease - No frequent vomiting - No medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Prior biologic therapy allowed - No concurrent growth factors to induce elevations in blood counts for the purposes of administration of study drug at scheduled dosing interval or to allow treatment with study drug at a higher dose Chemotherapy - More than 4 weeks since prior chemotherapy - No prior temozolomide - No other concurrent chemotherapy during study radiotherapy Endocrine therapy - Not specified Radiotherapy - Prior radiotherapy for local control or palliative therapy for painful bony lesions allowed - At least 4 weeks since prior radiotherapy to 15% of bone marrow (2 weeks for < 15% of bone marrow) and recovered - No prior radiotherapy to 50% of bone marrow - No prior radiotherapy to the brain, including stereotactic radiosurgery to a different lesion - Concurrent radiotherapy to painful bony lesions allowed provided no more than 15% of bone marrow is irradiated Surgery - Prior surgery for brain metastasis allowed Other - No other concurrent investigational agents - No other concurrent treatment for brain metastasis
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
H.Robins,  Study Chair,  University of Wisconsin Comprehensive Cancer Center


Additional Information:
Study ID Numbers:  CDR0000357567;  ECOG-E1F03
Study Start Date: 
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080938

Other Brain Metastases Studies:
1. Radiation Therapy With or Without Radiosurgery in Treating Patients With Brain Metastases

2. Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors

3. Stereotactic Radiation Therapy in Treating Patients With Brain Metastases

4. Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain

5. Evaluation of Memory Skills in Patients Receiving Radiation Therapy for Brain Metastases

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