Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer



Status:Terminated
Conditions:Lung Cancer, Lung Cancer, Cancer, Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:October 6, 2004
End Date:April 1, 2012

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A Phase III Trial Comparing Whole Brain Radiation and Stereotactic Radiosurgery Alone Versus With Temozolomide or Erlotinib in Patients With Non-Small Cell Lung Cancer and 1-3 Brain Metastases

This randomized phase III trial is studying whole-brain radiation therapy and stereotactic
radiosurgery with or without temozolomide or erlotinib to see how well they work compared to
whole-brain radiation therapy and stereotactic radiosurgery in treating patients with brain
metastases secondary to non-small cell lung cancer. Radiation therapy uses high-energy x-rays
to kill tumor cells. Stereotactic radiosurgery may be able to deliver x-rays directly to the
tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as
temozolomide, work in different ways to stop tumor cells from dividing so they stop growing
or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for
their growth and by blocking blood flow to the tumor. It is not yet known whether radiation
therapy and stereotactic radiosurgery are more effective with or without temozolomide or
erlotinib in treating brain metastases.

PRIMARY OBJECTIVES:

I. Compare survival in patients with non-small cell lung cancer and brain metastases treated
with whole brain radiotherapy and stereotactic radiosurgery with vs without temozolomide or
erlotinib.

SECONDARY OBJECTIVES:

I. Compare time to CNS progression in patients treated with these regimens. II. Compare
quality-adjusted survival in patients treated with these regimens. III. Compare 3-month
quality of life in patients treated with these regimens. IV. Compare the 6-month performance
status of patients treated with these regimens.

V. Compare 6-month steroid dependence in patients treated with these regimens. VI. Compare
cause of death (neurologic vs other) in patients treated with these regimens.

VII. Determine the effects of non-protocol chemotherapy in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
and the presence of extracranial metastases (< 65 years old AND no extracranial metastases vs
≥ 65 years old OR extracranial metastases), number of metastases (1 vs 2 or 3), and extent of
extracranial disease (none vs present). Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and
15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.

ARM II: Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the
first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4
weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on
days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity.

ARM III: Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the
first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.

In all arms, patients with recurrent brain metastases may undergo additional stereotactic
radiosurgery.

Quality of life is assessed at baseline and at 3, 6, 9, 12, 18, and 24 months.

Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then
annually thereafter.

Inclusion Criteria:

- Histologically confirmed non-small cell lung cancer

- One to 3 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the
following criteria:

- Well circumscribed tumor(s)

- Maximum diameter ≤ 4.0 cm

- If multiple lesions are present and one lesion is at the maximum diameter,
the other lesions must not exceed 3.0 cm in maximum diameter

- No metastases within 10 mm of the optic apparatus such that a portion of the
optic nerve or chiasm would be included in the high-dose stereotactic
radiosurgery boost field

- No metastases in the brainstem, midbrain, pons, or medulla

- No prior complete resection of all known brain metastases

- Subtotal resection allowed provided residual disease is ≤ 4.0 cm in maximum
diameter

- No clinical or radiographic evidence of progression (other than study lesion[s])
within the past month

- Patients with brain metastases at initial presentation do not require 1 month of
scans documenting stable disease

- Stable extracranial metastases allowed

- No known or pre-existing liver metastases

- No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation

- Synchronous brain metastases at initial diagnosis allowed

- Performance status - Zubrod 0-1

- Hemoglobin ≥ 8 g/dL

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3

- AST < 2 times upper limit of normal (ULN)

- Alkaline phosphatase < 2 times ULN unless due to elevated bone metastases

- Total bilirubin normal

- Lactic dehydrogenase < 2 times ULN

- Creatinine < 1.5 times ULN

- No clinically active interstitial lung disease

- Chronic stable asymptomatic radiographic changes allowed

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- Neurologic function status 0-2

- No other major medical illness or psychiatric impairment that would preclude study
participation

- No history of allergic reaction attributed to compounds of similar chemical or
biologic composition to erlotinib or temozolomide

- No concurrent immunotherapy

- No concurrent biologic therapy, excluding growth factors and epoetin alfa

- No prior temozolomide or erlotinib

- No other concurrent chemotherapy during study radiotherapy

- Other concurrent chemotherapy allowed after study radiotherapy, except for the
following:

- Temozolomide or erlotinib (arm I only)

- Erlotinib (arm II only)

- Temozolomide (arm III only)

- No prior cranial radiotherapy

- No concurrent intensity-modulated radiotherapy

- Concurrent radiotherapy to painful bone lesions allowed

- No concurrent radiotherapy to more than 15% of bone marrow

- No other concurrent therapy for brain metastases unless a recurrence is detected

- More than 30 days since prior investigational drugs

- No concurrent enzyme-inducing antiepileptic drugs including, but not limited to, any
of the following (for patients randomized to receive erlotinib):

- Phenytoin

- Carbamazepine

- Rifampin

- Phenobarbital

- Primidone

- Oxcarbazepine

- No other concurrent investigational drugs

- No concurrent Hypericum perforatum (St. John's wort)

- No drugs that alter gastric pH (e.g., proton pump inhibitors or H2 antagonists) within
4 hours after erlotinib administration (arm III patients only)
We found this trial at
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1831 Fifth Avenue
Columbus, Georgia 31904
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John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
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301 University Blvd
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200 North Park Street
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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401 College Street
Richmond, Virginia 23298
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Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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60 Crittenden Blvd # 70
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
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Arlington, Texas 76012
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Arlington Heights, Illinois 60005
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Asheville, North Carolina 28801
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22 South Greene Street
Baltimore, Maryland 21201
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University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Baltimore, Maryland 21229
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55 Fruit St
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201 E Nicollet Blvd
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171 Ashley Avenue
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303 East Superior Street
Chicago, Illinois 60611
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2049 E 100th St
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4050 Coon Rapids Blvd NW
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4160 John R St #2122
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6401 France Ave S
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2200 Randallia Drive
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601 South Rancho Drive Suite C-26
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9200 W Wisconsin Ave
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800 E 28th St
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5121 S Cottonwood St
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4755 Ogletown-Stanton Road
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600 Gresham Dr
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Philadelphia, Pennsylvania 19107
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3635 Vista at Grand Ave.
Saint Louis, Missouri 63110
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3850 Park Nicollet Blvd
Saint Louis Park, Minnesota 55416
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2000 Circle of Hope Dr
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8th Ave & C St
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Seattle, Washington 98101
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