Temozolomide and Radiation Therapy in Treating Patients With Brain Metastasis Secondary to Non-Sm… (NCT00080938) | Clinical Trial Compass
CompletedPhase 2
Temozolomide and Radiation Therapy in Treating Patients With Brain Metastasis Secondary to Non-Small Cell Lung Cancer
26 participantsStarted 2005-12-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Number of Patients With Intracranial Response
Timeframe: assessed every cycle while on treatment, then every 3 months for 2 years