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A Phase II Study of Temozolomide and Radiation Therapy in Patients With Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)

Phase 2
18 Years
Not Enrolling
Lung Cancer, Metastatic Cancer

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Trial Information

A Phase II Study of Temozolomide and Radiation Therapy in Patients With Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)



- Determine the intracranial response rate in patients with brain metastasis secondary to
non-small cell lung cancer treated with whole brain radiotherapy and temozolomide.


- 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

Patients were followed every 3 months for 2 years.

ACCRUAL: A total of 26 patients were accrued for this study.

Inclusion Criteria:

- Histologically confirmed non-small cell lung cancer (NSCLC), including the following

- 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

- 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

- 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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients With Intracranial Response

Outcome Description:

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

Outcome Time Frame:

assessed every cycle while on treatment, then every 3 months for 2 years

Safety Issue:


Principal Investigator

H. I. Robins, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison


United States: Federal Government

Study ID:




Start Date:

October 2005

Completion Date:

February 2009

Related Keywords:

  • Lung Cancer
  • Metastatic Cancer
  • recurrent non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • squamous cell lung cancer
  • adenocarcinoma of the lung
  • large cell lung cancer
  • bronchoalveolar cell lung cancer
  • adenosquamous cell lung cancer
  • tumors metastatic to brain
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary