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

NCT00280748 | Terminated Phase 2 Results DMC

• 2 other identifiers: LCCC 0409CDR0000551069
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer; Metastatic Cancer

Keywords

recurrent non-small cell lung cancer; stage IV non-small cell lung cancer; tumors metastatic to brain

Outcome Measures

Primary Outcomes (1)

• Response of Intracranial Metastases (Complete and Partial Response)

  Radiographic response will be measured by RECIST, Response Evaluation Criteria In Solid Tumors Criteria, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  126 days

Secondary Outcomes (6)

• Number of Subjects Experiencing Adverse Events

  maximum 5 months

• Estimate the Overall Survival of Patients Treated With This Regimen.

  4 years

• Evaluate the Functional Status of Patients Treated With This Regimen.

  baseline functional status only

• Neurological Function by Radiation Oncology Group (RTOG) Neurological Function Classification

  At Baseline, 30 days, and at end of treatment (maximum 5 months).

• Neurological Function by Mini Mental State Examination

  Baseline (pre-treatment), 30 days (Cycle 2 Day 1), and maximum 5 months (end of treatment).

Study Arms (1)

Single Arm Study

OTHER

Single Arm Study

Drug: pemetrexed disodium; Radiation: radiation therapy

Interventions

pemetrexed disodium DRUG

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

Also known as: Alimta

Single Arm Study

radiation therapy 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

Single Arm Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Alamance Oncology/Hematology Associates, LLP

Burlington, North Carolina, 27216, United States

Location

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

Chapel Hill, North Carolina, 27599-7295, United States

Location

Related Links

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

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

Pemetrexed; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Therapeutics

Results Point of Contact

• Title: Robin V. Johnson
• Organization: UNC Lineberger Comprehensive Cancer Center

Robin_V_Johnson@med.unc.edu

919-966-1125

Study Officials

• Thomas E. Stinchcombe, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2006
• First Posted: January 23, 2006
• Study Start: May 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: April 1, 2009
• Last Updated: June 23, 2017
• Results First Posted: June 23, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)