Full Text View
Tabular View
No Study Results Posted
Related Studies
Temozolomide and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastasis Secondary to Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: April 7, 2004   Last Updated: August 29, 2009   History of Changes
Sponsor: Eastern Cooperative Oncology Group
Collaborator: 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
Lung Cancer
Metastatic 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:


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
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:
No publications provided

Study ID Numbers: CDR0000357567, ECOG-E1F03
Study First Received: April 7, 2004
Last Updated: August 29, 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
tumors metastatic to brain

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Temozolomide
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplastic Processes
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
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2009