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

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ClinicalTrials.gov Identifier: NCT00280748
Recruitment Status : Terminated (Slow accrual)
First Posted : January 23, 2006
Results First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lung Cancer
Metastatic Cancer
Interventions Drug: pemetrexed disodium
Radiation: radiation therapy
Enrollment 10
Recruitment Details Subjects were recruited from 2 institutions between May 2005 and April 2008.
Pre-assignment Details  
Arm/Group Title Single Arm Study
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Single Arm Study

pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days

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

Period Title: Overall Study
Started 10
Completed 6
Not Completed 4
Reason Not Completed
Decline in performance             3
Extra-cranial disease progression             1
Arm/Group Title Single Arm Study
Hide Arm/Group Description

Single Arm Study

pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days

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

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
62.5
(46 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
4
  40.0%
Male
6
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
1
  10.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  10.0%
White
8
  80.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
Karnofsky Performance Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
KPS 90-100; minor symptoms of disease
3
  30.0%
KPS 80-90; some symptoms of disease
0
   0.0%
KPS 70-80; unable to carry on all normal activity
6
  60.0%
KPS unknown
1
  10.0%
1.Primary Outcome
Title Response of Intracranial Metastases (Complete and Partial Response)
Hide Description 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.
Time Frame 126 days
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 10 patients, four patients were unevaluable due to extra-cranial disease progression or decline in performance status prevent re-evaluation.
Arm/Group Title Single Arm Study
Hide Arm/Group Description:

Single Arm Study

pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days

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

Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
partial response
1
  16.7%
stable disease
3
  50.0%
progressive disease
2
  33.3%
2.Secondary Outcome
Title Number of Subjects Experiencing Adverse Events
Hide Description Toxicities was assessed using Common Terminology Criteria for Adverse Events (CTCAE) grading scale. Only toxicities with attribution to chemotherapy of "definite" or "probable" are considered, as determined by treating physician.
Time Frame maximum 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received treatment were evaluated
Arm/Group Title Single Arm Study
Hide Arm/Group Description:

Single Arm Study

pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days

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

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
Anemia
2
  20.0%
Alpecia
2
  20.0%
Nausea
6
  60.0%
Anorexia
1
  10.0%
Pruritic rash on head
1
  10.0%
Cramps
1
  10.0%
Acute bronchitis
1
  10.0%
Blurred vision
1
  10.0%
Dry skin
1
  10.0%
Fatigue
2
  20.0%
3.Secondary Outcome
Title Estimate the Overall Survival of Patients Treated With This Regimen.
Hide Description Patients were followed for survival from start of treatment until death from any cause (up to 4 years)
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Four patients were unevaluable due to extra-cranial disease progression or decline in performance status preventing re-evaluation.
Arm/Group Title Single Arm Study
Hide Arm/Group Description:

Single Arm Study

pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days

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

Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: months
6.0
(1.7 to 8.3)
4.Secondary Outcome
Title Evaluate the Functional Status of Patients Treated With This Regimen.
Hide Description Functional status evaluated using the Karnofsky functional status scale. The Karnofsky Performance Scale (KPS) Index allows patients to be classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death.
Time Frame baseline functional status only
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm Study
Hide Arm/Group Description:

Single Arm Study

pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days

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

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
KPS 90-100; minor symptoms of disease
3
  30.0%
KPS 80-90; some symptoms of disease
0
   0.0%
KPS 70-80; unable to carry on all normal activity
6
  60.0%
KPS unknown
1
  10.0%
5.Secondary Outcome
Title Neurological Function by Radiation Oncology Group (RTOG) Neurological Function Classification
Hide Description

A classification score defined as follows:

  1. Able to work or to perform normal activities: neurological findings minor or absent
  2. Able to carry out normal activities with minimal difficulties. Neurological impairment does not require nursing care or hospitalization
  3. Seriously limited in performing normal activities. Requiring nursing care or hospitalization. Patients confined to bed or wheelchair or have significant intellectual impairment
  4. Unable to perform even minimal normal activities. Requiring hospitalization and constant nursing care and feeding. Patients unable to communicate or in coma.A higher score indicates worse function.
Time Frame At Baseline, 30 days, and at end of treatment (maximum 5 months).
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated due to slow enrollment and the planned statistical analyses could not be performed due to limit sample size. The data represents the results of patients enrolled and treated on the trial.
Arm/Group Title Single Arm Study
Hide Arm/Group Description:

Single Arm Study

pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days

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

Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: scores on a scale
Pre-Treatment Number Analyzed 10 participants
1.6
(1 to 2)
Cycle 2 Number Analyzed 9 participants
1.9
(1 to 3)
End of Treatment Number Analyzed 6 participants
2.2
(1 to 3)
6.Secondary Outcome
Title Neurological Function by Mini Mental State Examination
Hide Description The Mini Mental State Examination is a 30-point questionnaire that is used to measure cognitive impairment. Score totals range from normal cognition (24-30 points), mild impairment (19-23 points), moderate impairment (10-18 points), to severe impairment (≤9 points).
Time Frame Baseline (pre-treatment), 30 days (Cycle 2 Day 1), and maximum 5 months (end of treatment).
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated due to slow enrollment and the planned statistical analyses could not be performed due to limited sample size. The data represents the results of patients enrolled and treated on the trial.
Arm/Group Title Single Arm Study
Hide Arm/Group Description:

Single Arm Study

pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days

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

Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: score on the scale
Pre-Treatment Number Analyzed 10 participants
28
(24 to 30)
Cycle 2 Day 1 Number Analyzed 10 participants
28.2
(25 to 30)
End of treatment Number Analyzed 6 participants
27.7
(21 to 30)
7.Secondary Outcome
Title Response of Patients With Extracranial Disease Treated With Pemetrexed
Hide Description Response was measured by Response Evaluation Criteria In Solid Tumors RECIST criteria v1.0. Complete Response (CR) - Disappearance of all lesions Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Stable Disease (SD) - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD) - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing nontarget lesions.
Time Frame maximum 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated due to slow enrollment and the planned statistical analyses could not be performed due to limit sample size. The data represents the results of patients enrolled and treated on the trial.
Arm/Group Title Single Arm Study
Hide Arm/Group Description:

Single Arm Study

pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days

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

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
partial response
2
  20.0%
stable disease
3
  30.0%
progressive disease
1
  10.0%
missing data
4
  40.0%
Time Frame Adverse events were monitored up to 30 days after end of treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm Study
Hide Arm/Group Description

Single Arm Study

pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days

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

All-Cause Mortality
Single Arm Study
Affected / at Risk (%)
Total   10/10 (100.00%)    
Hide Serious Adverse Events
Single Arm Study
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
Nervous system disorders   
Dizziness * 1  1/10 (10.00%)  1
hallucinations * 1  1/10 (10.00%)  1
Vascular disorders   
pulmonary embolus * 1  1/10 (10.00%)  1
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Arm Study
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Blood and lymphatic system disorders   
Anemia * 1  2/10 (20.00%)  2
face/upper/lower extremity swelling * 1  1/10 (10.00%)  1
swelling-lower extremities * 1  1/10 (10.00%)  1
Eye disorders   
Blurred vision * 1  1/10 (10.00%)  1
Dry Eyes * 1  1/10 (10.00%)  1
Gastrointestinal disorders   
Anorexia * 1  4/10 (40.00%)  4
Constipation * 1  2/10 (20.00%)  2
Diarrhea * 1  1/10 (10.00%)  1
Flatulence * 1  1/10 (10.00%)  1
Hemmorroids * 1  1/10 (10.00%)  1
Mucositis * 1  1/10 (10.00%)  1
Nausea * 1  8/10 (80.00%)  8
Vomiting * 1  1/10 (10.00%)  1
General disorders   
Right maxillary pain with drainage * 1  1/10 (10.00%)  1
abdominal pain * 1  1/10 (10.00%)  1
chest pain * 1  1/10 (10.00%)  1
Headache * 1  2/10 (20.00%)  2
Hip pain * 1  1/10 (10.00%)  1
left lower quadrant pain * 1  1/10 (10.00%)  1
Pain * 1  1/10 (10.00%)  1
rib cage pain * 1  1/10 (10.00%)  1
right foot 4th toes numbness * 1  1/10 (10.00%)  1
Infections and infestations   
Acute bronchitis * 1  1/10 (10.00%)  1
UTI * 1  1/10 (10.00%)  2
Metabolism and nutrition disorders   
difficulty sleeping * 1  1/10 (10.00%)  1
fatigue * 1  2/10 (20.00%)  2
Hypokalemia * 1  1/10 (10.00%)  1
Hyponatremia * 1  1/10 (10.00%)  1
weakness * 1  2/10 (20.00%)  2
weight loss * 1  2/10 (20.00%)  2
Musculoskeletal and connective tissue disorders   
Cramps * 1  1/10 (10.00%)  1
Nervous system disorders   
Anxiety * 1  2/10 (20.00%)  2
Confusion * 1  3/10 (30.00%)  3
depression * 1  2/10 (20.00%)  2
Left eye visual disturbance * 1  1/10 (10.00%)  1
memory impairment * 1  1/10 (10.00%)  1
Transient ischemic attack * 1  1/10 (10.00%)  1
Renal and urinary disorders   
Dysuria * 1  1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
cough * 1  1/10 (10.00%)  1
dyspnea * 1  3/10 (30.00%)  3
Skin and subcutaneous tissue disorders   
Alopecia * 1  3/10 (30.00%)  3
dry skin * 1  1/10 (10.00%)  1
Erythemic/vesicular papule-right temple * 1  1/10 (10.00%)  1
insect bite * 1  1/10 (10.00%)  1
pruritic rash on head * 1  1/10 (10.00%)  1
Vascular disorders   
INR * 1  1/10 (10.00%)  1
Nosebleed * 1  1/10 (10.00%)  1
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robin V. Johnson
Organization: UNC Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
EMail: Robin_V_Johnson@med.unc.edu
Layout table for additonal information
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00280748    
Other Study ID Numbers: LCCC 0409
CDR0000551069 ( Other Identifier: PDQ number )
First Submitted: January 19, 2006
First Posted: January 23, 2006
Results First Submitted: April 3, 2017
Results First Posted: June 23, 2017
Last Update Posted: June 23, 2017