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Whole-Brain Radiation Therapy and Pemetrexed in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00280748
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with pemetrexed may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving whole-brain radiation therapy together with pemetrexed works in treating patients with brain metastases from non-small cell lung cancer.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Lung Cancer
Drug: pemetrexed disodium
Procedure: radiation therapy
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Pemetrexed disodium Pemetrexed
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Treatment of Brain Metastases From Non-Small Cell Lung Cancer With Concurrent Whole Brain Radiation Therapy and Pemetrexed

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

Primary Outcome Measures:
  • Response of intracranial metastases (complete and partial response) [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2005
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Estimate the response in patients with intracranial brain metastases from non-small cell lung cancer treated with whole-brain radiotherapy and pemetrexed disodium.

Secondary

  • Determine the toxicity of this regimen in these patients.
  • Estimate the overall survival of patients treated with this regimen.
  • Evaluate the functional status of patients treated with this regimen.
  • Assess neurological function and progression in patients treated with this regimen.
  • Determine the response of patients with extracranial disease treated with pemetrexed disodium.

OUTLINE: Patients undergo whole-brain radiotherapy 5 days a week for 3 weeks beginning on day 1. Patients also receive pemetrexed disodium IV on day 1, 2, or 3 and day 28 of course 1, and on day 1 of each subsequent course. Treatment with pemetrexed disodium repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 30 days and then every 2 months for 2 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
  • Must have evidence of brain metastases by MRI or CT scan

    • No single brain metastases or oligometastatic disease amenable to surgical resection or radiosurgery
  • Relapsed NSCLC with brain metastases allowed
  • Not a candidate for double-agent or platinum-based chemotherapy
  • No leptomeningeal metastases
  • No clinically relevant (defined by physical exam) pleural effusions or ascites that cannot be controlled with drainage or other procedures

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100% OR ≥ 70 years of age
  • Life expectancy > 3 months
  • ANC > 1,500/mm³
  • Platelet count > 100,000/mm³
  • Hemoglobin ≥ 8 g/dL
  • AST and ALT < 3 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • Creatinine clearance ≥ 45 mL/min
  • No contraindication or intolerance to corticosteroid therapy
  • No other malignancies within the past 5 years and disease-free OR prognosis is best defined by the NSCLC in the opinion of the attending physician
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No HIV positivity
  • No severe hypersensitivity to pemetrexed disodium
  • Able to discontinue NSAIDs for ≥ 5 days
  • No history of underlying dementia, Parkinson's disease, or Alzheimer's disease
  • Able to take vitamins, folic acid, and corticosteroids

PRIOR CONCURRENT THERAPY:

  • Recovered from prior oncologic or major surgery
  • Prior resection of all brain metastases or only site of brain metastases allowed provided there is radiologically evaluable intracranial metastases
  • No prior cranial irradiation, including stereotactic radiosurgery
  • More than 30 days since prior nonapproved or investigational drug
  • No other concurrent chemotherapy, immunotherapy, hormonal therapy, radiotherapy, surgery, or experimental medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280748

Locations
United States, North Carolina
Alamance Oncology/Hematology Associates, LLP
BURLINGTON, North Carolina, United States, 27216
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Thomas E. Stinchcombe, MD UNC Lineberger Comprehensive Cancer Center
  More Information

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

Study ID Numbers: CDR0000551069, UNC-LCCC-0409
Study First Received: January 19, 2006
Last Updated: January 2, 2009
ClinicalTrials.gov Identifier: NCT00280748  
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
adult tumors metastatic to brain

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Central Nervous System Neoplasms
Recurrence
Carcinoma
Folic Acid
Pemetrexed
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasm Metastasis
Carcinoma, Non-Small-Cell Lung
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Respiratory Tract Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nervous System Diseases
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Therapeutic Uses

ClinicalTrials.gov processed this record on January 15, 2009