Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	ECOG-E1F03 E1F03, NCT00080938

Objectives

Primary

1. 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

1. Determine the time to radiological progression in patients treated with this regimen.
2. Determine the time to neurological progression (confirmed by MRI) in patients treated with this regimen.
3. Determine the overall survival of patients treated with this regimen.
4. Determine the toxicity of this regimen in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• More than 12 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

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

Outcomes

Time to CNS progression
Time to systemic (non-CNS) progression
Survival

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Minesh Mehta, MD, Protocol co-chair		Ph: 608-263-5009; 800-622-8922 Email: mehta@humonc.wisc.edu
H. Robins, MD, PhD, Protocol chair		Ph: 608-263-1416; 800-622-8922 Email: hirobins@facstaff.wisc.edu

Registry Information
Official Title		A Phase II Study of Temozolomide and Radiation Therapy in Patients with Brain Metastasis from Non-small Cell Lung Cancer (NSCLC)
Trial Start Date		2005-10-18
Registered in ClinicalTrials.gov		NCT00080938
Date Submitted to PDQ		2004-02-18
Information Last Verified		2007-03-13
NCI Grant/Contract Number		CA21115

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