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

Sponsors and Collaborators:	Eastern Cooperative Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00080938

Purpose

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors Lung Cancer	Drug: temozolomide Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study of Temozolomide and Radiation Therapy in Patients With Brain Metastasis From Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy

Drug Information available for: Temozolomide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Time to CNS progression [ Designated as safety issue: No ]
Time to systemic (non-CNS) progression [ Designated as safety issue: No ]
Survival [ Designated as safety issue: No ]

Estimated Enrollment:	53
Study Start Date:	October 2005

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 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 CNS progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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
  - 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

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

More than 12 weeks

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 10 g/dL

Hepatic

Bilirubin ≤ 2 times upper limit of normal (ULN)
AST and 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)

Renal

Creatinine ≤ 1.6 mg/dL

Other

HIV negative
No AIDS-related illness
No poor medical risks due to active nonmalignant systemic disease
No frequent vomiting
No medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Prior biologic therapy allowed
No 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

Chemotherapy

More than 4 weeks since prior chemotherapy
No prior temozolomide
No other concurrent chemotherapy during study radiotherapy

Endocrine therapy

Not specified

Radiotherapy

Prior radiotherapy for local control or palliative therapy for painful bony lesions 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
No prior radiotherapy to the brain, including stereotactic radiosurgery to a different lesion
No concurrent intensity modulated radiotherapy or 3-D cranial radiotherapy
Concurrent radiotherapy to painful bony lesions allowed provided no more than 15% of bone marrow is irradiated

Surgery

Prior surgery for brain metastasis allowed

Other

No other concurrent investigational agents
No other concurrent treatment for brain metastasis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080938

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Investigator:	Minesh P. Mehta, MD	University of Wisconsin, Madison
Study Chair:	H. I. Robins, MD, PhD	University of Wisconsin, Madison

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000357567, ECOG-E1F03
Study First Received:	April 7, 2004
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00080938 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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
adult tumors metastatic to brain

Study placed in the following topic categories:

Thoracic Neoplasms
Adenocarcinoma, Bronchiolo-Alveolar
Central Nervous System Neoplasms
Temozolomide
Recurrence
Carcinoma
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Neoplasm Metastasis
Non-small Cell Lung Cancer
Antineoplastic Agents, Alkylating
Adenocarcinoma of Lung
Adenocarcinoma
Alkylating Agents
Carcinoma, Non-Small-Cell Lung
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nervous System Diseases
Central Nervous System Neoplasms
Temozolomide
Pharmacologic Actions
Carcinoma
Neoplastic Processes
Neoplasms

Pathologic Processes
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Neoplasm Metastasis
Antineoplastic Agents, Alkylating
Alkylating Agents
Carcinoma, Non-Small-Cell Lung
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009