Status:
COMPLETED
Temozolomide and Radiation Therapy in Treating Patients With Brain Metastasis Secondary to Non-Small Cell Lung Cancer
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 radiati...
Detailed Description
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. Seco...
Eligibility Criteria
Inclusion
- 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
- At least 1 bidimensionally measurable brain metastasis
- Confirmed by MRI within the past two weeks, and computed tomography (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
- Age\>=18 years
- ECOG Performance status of 0-1
- More than 12 weeks of life expectancy
- Adequate hematologic, renal, and liver function as demonstrated by laboratory values performed within two weeks, inclusive, prior to administration of study drug or registration
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 10 g/dL
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and Alanine aminotransferase (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)
- Creatinine ≤ 1.6 mg/dL
- Fertile patients must use effective contraception
- Prior biologic therapy allowed
- More than 4 weeks since prior chemotherapy
- Prior radiotherapy for local control or palliative therapy for painful bony lesions allowed
- Prior surgery for brain metastasis 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
- Concurrent radiotherapy to painful bony lesions allowed provided no more than 15% of bone marrow is irradiated
Exclusion
- HIV positive
- AIDS-related illness
- Poor medical risks due to active nonmalignant systemic disease
- Frequent vomiting
- There is medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)
- Pregnant or nursing
- Prior temozolomide
- Prior radiotherapy to the brain, including stereotactic radiosurgery to a different lesion
- Concurrent intensity modulated radiotherapy or 3-D cranial radiotherapy
- Other concurrent investigational agents
- Other concurrent treatment for brain metastasis
- Other concurrent chemotherapy during study radiotherapy
- 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
Key Trial Info
Start Date :
December 20 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00080938
Start Date
December 20 2005
End Date
February 1 2009
Last Update
June 29 2023
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