Whole-Brain Radiation Therapy and Pemetrexed in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00280748
First received: January 19, 2006
Last updated: September 18, 2012
Last verified: September 2012
  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
Lung Cancer
Metastatic Cancer
Drug: pemetrexed disodium
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Response of intracranial metastases (complete and partial response) [ Time Frame: 126 days ] [ Designated as safety issue: No ]
    Radiographic response will be measured by RECIST, indicating if subject experienced a Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)


Secondary Outcome Measures:
  • Number of subjects experiencing adverse events [ Time Frame: 126 days ] [ Designated as safety issue: Yes ]
    Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE)grading scale.


Enrollment: 10
Study Start Date: May 2005
Study Completion Date: April 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: pemetrexed disodium
    500 mg/m2 once every 21 days up to 126 days
    Radiation: radiation therapy
    Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00280748     History of Changes
Other Study ID Numbers: LCCC 0409, CDR0000551069
Study First Received: January 19, 2006
Last Updated: September 18, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
recurrent non-small cell lung cancer
stage IV non-small cell lung cancer
tumors metastatic to brain

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014