A Phase II Study of Temozolomide and Radiation Therapy in Patients With Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)
Overview
- Phase
- Phase 2
- Intervention
- Temozolomide
- Conditions
- Lung Cancer
- Sponsor
- Eastern Cooperative Oncology Group
- Enrollment
- 26
- Primary Endpoint
- Number of Patients With Intracranial Response
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 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.
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. Secondary * Determine the time to radiological progression in patients treated with this regimen. * Determine the time to neurological progression (confirmed by magnetic resonance imaging (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 temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of neurologic (Central Nervous System, CNS) progression or unacceptable toxicity. Patients were followed every 3 months for 2 years. ACCRUAL: A total of 26 patients were accrued for this study.
Investigators
Eligibility 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
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
Arms & Interventions
Temozolomide and Radiation
Temozolomide:administered orally. Radiation: whole brain radiation therapy
Intervention: Temozolomide
Temozolomide and Radiation
Temozolomide:administered orally. Radiation: whole brain radiation therapy
Intervention: Radiation therapy
Outcomes
Primary Outcomes
Number of Patients With Intracranial Response
Time Frame: assessed every cycle while on treatment, then every 3 months for 2 years
Response was assessed per Response Evaluation Criteria in Solid Tumor (RECIST) by brain MRI in the 21 eligible and treated patients.Complete response (CR): complete disappearance of the clinically detectable malignant brain metastasis(es) being followed on MRI scan off corticosteroids and a stable or improving neurologic exam. Partial response (PR): greater than or equal to a 50% reduction in the sum of the product(s) of the maximal cross-sections on MRI scan with a stable or decreasing dose of corticosteroids and a stable or improving neurologic exam. Response = CR + PR
Secondary Outcomes
- Time to Non-CNS (Systemic) Progression(assessed every 3 months for 2 years)
- Overall Survival Time(assessed every 3 months for 2 years)
- 1-year Neurologic (Central Nervous System, CNS) Progression Free Rate(assessed every 3 months for 2 years)