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

NCT ID: NCT00280748

Last Updated: 2017-06-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2009-04-30

Brief Summary

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.

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.

Conditions

Lung Cancer; Metastatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm Study

Single Arm Study

Group Type: OTHER

pemetrexed disodium

Intervention Type: DRUG

500 mg/m2 once every 21 days up to 126 days

radiation therapy

Intervention Type: RADIATION

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

Interventions

pemetrexed disodium

500 mg/m2 once every 21 days up to 126 days

Intervention Type: DRUG

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

Intervention Type: RADIATION

Other Intervention Names

Alimta

Eligibility Criteria

Inclusion Criteria

• Karnofsky performance status 70-100% OR ≥ 70 years of age
• Life expectancy > 3 months
• Absolute neutrophil count (ANC) > 1,500/mm³
• Platelet count > 100,000/mm³
• Hemoglobin ≥ 8 g/dL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• Creatinine clearance ≥ 45 mL/min
• Able to take vitamins, folic acid, and corticosteroids

Exclusion Criteria

• Contraindication or intolerance to corticosteroid therapy
• 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
• Pregnant or nursing
• Positive pregnancy test
• Fertile patients must use effective contraception
• HIV positive
• Severe hypersensitivity to pemetrexed disodium
• Unable to discontinue NSAIDs for ≥ 5 days
• History of underlying dementia, Parkinson's disease, or Alzheimer's disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas E. Stinchcombe, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

Alamance Oncology/Hematology Associates, LLP

Burlington, North Carolina, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Related Links

https://clinicaltrials.gov/ct2/show/NCT00280748

Clinical trial summary from the National Cancer Institute's PDQ® database

Other Identifiers

CDR0000551069

Identifier Type: OTHER

Identifier Source: secondary_id

LCCC 0409

Identifier Type: -

Identifier Source: org_study_id