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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000551069 | Other Identifier | PDQ number |
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Slow accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Study | Other | Single Arm Study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed disodium | Drug | 500 mg/m2 once every 21 days up to 126 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Experiencing Adverse Events | 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. | maximum 5 months |
| Estimate the Overall Survival of Patients Treated With This Regimen. |
Not provided
DISEASE CHARACTERISTICS:
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 non-approved or investigational drug
No other concurrent chemotherapy, immunotherapy, hormonal therapy, radiotherapy, surgery, or experimental medications
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
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas E. Stinchcombe, MD | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alamance Oncology/Hematology Associates, LLP | Burlington | North Carolina | 27216 | United States | ||
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill |
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| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
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Subjects were recruited from 2 institutions between May 2005 and April 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Study | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
|
Patients were followed for survival from start of treatment until death from any cause (up to 4 years) |
| 4 years |
| Evaluate the Functional Status of Patients Treated With This Regimen. | 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. | baseline functional status only |
| Neurological Function by Radiation Oncology Group (RTOG) Neurological Function Classification | A classification score defined as follows:
| At Baseline, 30 days, and at end of treatment (maximum 5 months). |
| Neurological Function by Mini Mental State Examination | 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). | Baseline (pre-treatment), 30 days (Cycle 2 Day 1), and maximum 5 months (end of treatment). |
| Response of Patients With Extracranial Disease Treated With Pemetrexed | 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. | maximum 5 months |
| Chapel Hill |
| North Carolina |
| 27599-7295 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Study | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Karnofsky Performance Status | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Of the 10 patients, four patients were unevaluable due to extra-cranial disease progression or decline in performance status prevent re-evaluation. | Posted | Count of Participants | Participants | 126 days |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Experiencing Adverse Events | 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. | All patients who received treatment were evaluated | Posted | Count of Participants | Participants | maximum 5 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Estimate the Overall Survival of Patients Treated With This Regimen. | Patients were followed for survival from start of treatment until death from any cause (up to 4 years) | Four patients were unevaluable due to extra-cranial disease progression or decline in performance status preventing re-evaluation. | Posted | Median | Full Range | months | 4 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Evaluate the Functional Status of Patients Treated With This Regimen. | 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. | Posted | Count of Participants | Participants | baseline functional status only |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Neurological Function by Radiation Oncology Group (RTOG) Neurological Function Classification | A classification score defined as follows:
| 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. | Posted | Mean | Full Range | scores on a scale | At Baseline, 30 days, and at end of treatment (maximum 5 months). |
|
| ||||||||||||||||||||||||||||||
| Secondary | Neurological Function by Mini Mental State Examination | 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). | 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. | Posted | Mean | Full Range | score on the scale | Baseline (pre-treatment), 30 days (Cycle 2 Day 1), and maximum 5 months (end of treatment). |
|
| ||||||||||||||||||||||||||||||
| Secondary | Response of Patients With Extracranial Disease Treated With Pemetrexed | 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. | 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. | Posted | Count of Participants | Participants | maximum 5 months |
|
|
Adverse events were monitored up to 30 days after end of treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm Study | 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 | 10 | 10 | 1 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pulmonary embolus | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| hallucinations | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right maxillary pain with drainage | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| face/upper/lower extremity swelling | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| swelling-lower extremities | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry Eyes | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemmorroids | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| abdominal pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| chest pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Headache | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hip pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| left lower quadrant pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| rib cage pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| right foot 4th toes numbness | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Acute bronchitis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| UTI | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| difficulty sleeping | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| fatigue | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| weakness | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| weight loss | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cramps | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anxiety | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| depression | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Left eye visual disturbance | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| memory impairment | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Transient ischemic attack | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Erythemic/vesicular papule-right temple | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| insect bite | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| pruritic rash on head | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| INR | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nosebleed | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin V. Johnson | UNC Lineberger Comprehensive Cancer Center | 919-966-1125 | Robin_V_Johnson@med.unc.edu |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009362 | Neoplasm Metastasis |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D013812 | Therapeutics |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| KPS 70-80; unable to carry on all normal activity |
|
| KPS unknown |
|
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|
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|
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| Counts |
|---|
| Participants |
|
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