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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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 radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving temozolomide together with whole-brain radiation therapy works in treating patients with brain metastasis secondary to non-small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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