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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00596 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 62115 | |||
| CCCWFU # 62115 | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot phase II trial studies how well pemetrexed disodium works in treating patients with stage IV non-small cell lung cancer and an Eastern Cooperative Oncology Group (ECOG) performance status of 3. Performance status means how well patients are able to perform daily activities and care for themselves. Patients with a performance status of 3 have a limited ability to move around. Currently, only patients who are able to perform most of their daily activities may receive chemotherapy, due to the side effects it may cause. Pemetrexed disodium causes fewer side effects than many chemotherapy drugs and may help treat patients with stage IV non-small cell lung cancer and a lower performance status.
PRIMARY OBJECTIVES:
I. To evaluate the effect of single agent pemetrexed (pemetrexed disodium) on tumor progression in ECOG performance status 3 patients with stage IV non-squamous histology non-small cell lung cancer in a single arm pilot study.
II. To evaluate the effect of single agent pemetrexed on quality of life in ECOG performance status 3 patients with stage IV non-squamous histology non-small cell lung cancer in a single arm pilot study.
SECONDARY OBJECTIVES:
I. To evaluate toxicity associated with single agent pemetrexed on tumor progression in ECOG performance status 3 patients with stage IV non-squamous histology non-small cell lung cancer in a single arm pilot study.
OUTLINE:
Patients receive pemetrexed disodium intravenously (IV) over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 30 days and then every 6 weeks thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (pemetrexed disodium) | Experimental | Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment and Laboratory Biomarker Analysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life (QOL), Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) and QLQ-Lung Cancer 13-item (LC13) | Quality of life will be assessed at each treatment time (i.e. every three weeks). A longitudinal mixed models analysis will be used to look at QOL over the time course. A paired t-test will also be calculated to see if the average change is more than 0 (worsening) versus a two-sided alternative that the difference is 0 or better. Score range from 0-100 (1 = not at all, 2 = a little, 3 = quite a bit, or 4 = very much). The higher the score, the greater the change in the quality of life for the worse. | Baseline to 12 weeks |
| Time to Tumor Progression | It will be determined whether each patient has a progression (or dies) before or after 12 weeks. A 95% exact (Clopper Pearson) confidence interval will then be around the proportion with PFS greater than or equal to 12 weeks. If this confidence interval includes 50% then that would provide evidence that the therapy is potentially promising. If the upper bound of the confidence interval does not include 50% then this would indicate that the treatment may not be promising for patients. In addition, a Kaplan Meier survival curve will be constructed to describe the time to progression data. | The duration of time from the start of treatment to the time of progression, death, or date of last contact, assessed up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hematologic Toxicity, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | The number and type of toxicities observed during this protocol will be estimated, focusing on unexpected grade 3 or higher toxicities. No formal statistical tests will be done on these estimates. | Up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Grant | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Pemetrexed Disodium) | Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment and Laboratory Biomarker Analysis. Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV Quality-of-Life Assessment: QOL studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 13, 2017 |
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| Pemetrexed Disodium |
| Drug |
Given IV |
|
|
| Quality-of-Life Assessment | Other | QOL studies |
|
|
| Overall Survival | Examined by estimating a Kaplan-Meier survival curve using all patients enrolled. | The duration of time from the start of treatment to date of death or date of last contact, assessed up to 2 years |
| Response Rate | Response rate will be estimated every 6 weeks for patients, and these estimates will be presented with confidence intervals. | Up to 2 years |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Pemetrexed Disodium) | Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment and Laboratory Biomarker Analysis. Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV Quality-of-Life Assessment: QOL studies |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Change in Quality of Life (QOL), Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) and QLQ-Lung Cancer 13-item (LC13) | Quality of life will be assessed at each treatment time (i.e. every three weeks). A longitudinal mixed models analysis will be used to look at QOL over the time course. A paired t-test will also be calculated to see if the average change is more than 0 (worsening) versus a two-sided alternative that the difference is 0 or better. Score range from 0-100 (1 = not at all, 2 = a little, 3 = quite a bit, or 4 = very much). The higher the score, the greater the change in the quality of life for the worse. | Posted | Mean | Standard Error | score on a scale | Baseline to 12 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Time to Tumor Progression | It will be determined whether each patient has a progression (or dies) before or after 12 weeks. A 95% exact (Clopper Pearson) confidence interval will then be around the proportion with PFS greater than or equal to 12 weeks. If this confidence interval includes 50% then that would provide evidence that the therapy is potentially promising. If the upper bound of the confidence interval does not include 50% then this would indicate that the treatment may not be promising for patients. In addition, a Kaplan Meier survival curve will be constructed to describe the time to progression data. | Posted | Median | 95% Confidence Interval | months | The duration of time from the start of treatment to the time of progression, death, or date of last contact, assessed up to 2 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Hematologic Toxicity, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | The number and type of toxicities observed during this protocol will be estimated, focusing on unexpected grade 3 or higher toxicities. No formal statistical tests will be done on these estimates. | Posted | Count of Participants | Participants | Up to 30 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Examined by estimating a Kaplan-Meier survival curve using all patients enrolled. | Posted | Median | 95% Confidence Interval | months | The duration of time from the start of treatment to date of death or date of last contact, assessed up to 2 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Response Rate | Response rate will be estimated every 6 weeks for patients, and these estimates will be presented with confidence intervals. | Four patients died prior to the 2nd cycle of treatment when this measure was evaulated. | Posted | Count of Participants | Participants | Up to 2 years |
|
|
30 days after the last study is administered
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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 | Treatment (Pemetrexed Disodium) | Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment and Laboratory Biomarker Analysis. Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV Quality-of-Life Assessment: QOL studies | 4 | 13 | 12 | 13 | 12 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Death, NOS | General disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE version 4.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE version 4.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE version 4.0 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE version 4.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE version 4.0 | Systematic Assessment |
| |
| CD4 lymphocytes decreased | Investigations | CTCAE version 4.0 | Systematic Assessment |
| |
| Cardiac disorders, other | Cardiac disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Chills | General disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE version 4.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE version 4.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE version 4.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Electrocardiogram QT corrected interval prolonged | Investigations | CTCAE version 4.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| General disorders and administration site disorders, other | General disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
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| Hypernatremia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE version 4.0 | Systematic Assessment |
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| Investigations, other | Investigations | CTCAE version 4.0 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | CTCAE version 4.0 | Systematic Assessment |
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| Localized edema | General disorders | CTCAE version 4.0 | Systematic Assessment |
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| Lung infection | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE version 4.0 | Systematic Assessment |
| |
| Metabolism and nutrition disorders, other | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Mucositis, oral | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE version 4.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | CTCAE version 4.0 | Systematic Assessment |
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| Pain | General disorders | CTCAE version 4.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE version 4.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | Systematic Assessment |
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| Rash pustular | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | CTCAE version 4.0 | Systematic Assessment |
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| Skin and subcutaneous tissue disorders, other | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | Systematic Assessment |
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| Stomach pain | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | CTCAE version 4.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
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| Watering eyes | Eye disorders | CTCAE version 4.0 | Systematic Assessment |
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| Weight loss | Investigations | CTCAE version 4.0 | Systematic Assessment |
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| White blood cell decreased | Investigations | CTCAE version 4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Nurse | Wake Forest University Health Sciences | 336-716-2121 | saverill@wakehealth.edu |
| Nov 1, 2019 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 21, 2018 | Oct 5, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| 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 |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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