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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-US-X011 |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced NSCLC. This study will serve to define the role of next generation agents in a new combination regimen in the treatment of advanced NSCLC. This combination regimen may ultimately be important in further expanding treatment options for patients while improving survival, quality of life, and symptom control compared with platinum-based combination regimens - and with acceptable toxicity.
Upon determination of eligibility, patients will be receive:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed | Drug | 500mg/m2 IV over 10 min, Day 1, prior to gemcitabine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause. | 18 months |
| Overall Survival (OS) |
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Inclusion Criteria:
To be included in this study, you must meet the following criteria:
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
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| Name | Affiliation | Role |
|---|---|---|
| David R. Spigel, MD | SCRI Development Innovations, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20421819 | Result | Spigel DR, Hainsworth JD, Barton JH, Patton JF, Zubkus JD, Simons L, Griner P, Burris HA 3rd, Greco FA. Phase II study of biweekly pemetrexed and gemcitabine in patients with previously untreated advanced non-small cell lung cancer. J Thorac Oncol. 2010 Jun;5(6):841-5. doi: 10.1097/JTO.0b013e3181d737e3. |
| Label | URL |
|---|---|
| Published article in the Journal of Thoracic Oncology | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Overall Response Rate | Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. | All patients were assessed for response. | Posted | Number | 95% Confidence Interval | Percentage of participants | 18 months |
|
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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 | Intervention | Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered Mental Status | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Hainsworth, MD | Sarah Cannon Research Institute | 1-877-691-7274 | asksarah@scresearch.net |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Gemcitabine | Drug | 1500mg/m2, 30min IV |
|
|
OS was measured from the date of study entry until the date of death.
| 18 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Progression-free Survival (PFS) | PFS was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause. | All patients were assessed for PFS. | Posted | Median | 95% Confidence Interval | Months | 18 months |
|
|
|
| Secondary | Overall Survival (OS) | OS was measured from the date of study entry until the date of death. | All patients were assessed for OS. | Posted | Median | 95% Confidence Interval | Months | 18 months |
|
|
|
| 39 |
| 72 |
| 72 |
| 72 |
| Cardiac General - Other (Congestive Heart Failure) | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| CNS cerebrovascular ischemia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Death not associated with CTCAE term - Disease Progression NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pancreatic endocrine: glucose intolerance | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Febrile Neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fracture (Limb) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage, GI | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypoxemia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection - Other (Cellulitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection - Other (Pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neurology - Other (Spinal Cord Compression) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Gastrointestinal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pancytopenia (NOS) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pulmonary/Upper Respiratory - Other (Post obstructive lung process) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Supraventricular and nodal arrhythmia - Atrial Arrhythmia (NOS) | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Supraventricular and nodal arrhythmia - Atrial Fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Supraventricular and nodal arrhythmia - Atrial Flutter | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Supraventricular and nodal arrhythmia - Supraventricular tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Joints | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cardiac Toxicity | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Febrile Neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection (NOS) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - muscles | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Peripheral Neuropathy NOS | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pulmonary symptoms | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Skin Toxicity | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at the site.
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| 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 |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |