| ID | Type | Description | Link |
|---|---|---|---|
| H3E-US-JMGA |
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This study aims to determine how successful the chemotherapy regimen of Pemetrexed plus cisplatin before surgery is at killing all the tumor so that none is left at the time of surgery. Following surgery, all eligible patients will receive radiation to the chest. How patients respond, whether the cancer returns and if so, where, will also be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | chemotherapy, surgery then chest radiation x 54 gray (Gy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | 500 mg/m2, intravenous (IV), every 21 days x 4 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response | Number of participants with results of pathological review that indicated a complete response. Pathological complete response should be evaluated at the time of surgery (Extrapleural Pneumonectomy [EPP]). Resected tissue or pleural fluid should be sent for pathological and histological evaluation. | Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| The 1 and 2 Year Disease-Free Survival Rate (Percentage) | Kaplan-Meier estimates of the percentage of participants still alive at 1-year and 2-years, based upon the total number of participants who had surgery. | 1 year and 2 years |
| Overall Tumor Response |
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Inclusion Criteria:
Patients will be clinically staged using AJCC/UICC TNM staging criteria. Eligible stages:
Performance status of 0 to 1 on the ECOG performance status schedule.
No prior systemic chemotherapy and no prior intracavitary cytotoxic drugs or immunomodulators, unless given for the purpose of chemical pleurodesis
No previous radiation therapy
Estimated life expectancy of at least 12 weeks
Exclusion Criteria:
Patients will be excluded if they meet ANY of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Francisco | California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23324131 | Derived | Federico R, Adolfo F, Giuseppe M, Lorenzo S, Martino DT, Anna C, Adriano P, Gino C, Francesca R, Matteo C, Gbenga K, Paolo M, Francesco F. Phase II trial of neoadjuvant pemetrexed plus cisplatin followed by surgery and radiation in the treatment of pleural mesothelioma. BMC Cancer. 2013 Jan 16;13:22. doi: 10.1186/1471-2407-13-22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed | pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| cisplatin | Drug | 75 mg/m2, intravenous (IV), every 21 days x 4 cycles |
|
The frequency of best overall tumor response summarized by response category. The best (unconfirmed) response recorded from the start of chemotherapy treatment until disease progression/recurrence, start of any further anti-tumor therapy, or time of surgery whichever comes first. |
| baseline to measured progressive disease |
| Time to Treatment Failure | Time to relapse (treatment failure) is measured in months and calculated as (Date of first surgery - Date of first relapse after surgery + 1)/(365.25/12). Time to relapse will be censored at the date of the last visit or start date of further anti-tumor therapy or intervention, whichever comes first. | baseline to stopping treatment |
| Time to Progressive Disease | Number of months between the first dose date and the date of first disease progression or death as a result of any cause, whichever comes first. | baseline to measured progressive disease |
| Overall Survival Time | Number of months between the first dose date and the date of death as a result of any cause. Overall survival time calculated as (Date of death - First dose date + 1)/(365.25/12). | baseline to date of death from any cause |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chicago | Illinois | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Baltimore | Maryland | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Boston | Massachusetts | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Detroit | Michigan | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | New York | New York | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Houston | Texas | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed | pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy) |
| 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 |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Disease Stage at Time of Study Entry | Number | participants |
| |||||||||||||||||||||||
| Eastern Cooperative Oncology Group Performance Status | Number | participants |
| |||||||||||||||||||||||
| Initial Pathological Diagnosis | Number | participants |
| |||||||||||||||||||||||
| Race/Ethnicity | Number | participants |
| |||||||||||||||||||||||
| Time from Initial Pathological Diagnosis to Enrollment | Mean | Standard Deviation | months |
|
| 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 | Pathological Complete Response | Number of participants with results of pathological review that indicated a complete response. Pathological complete response should be evaluated at the time of surgery (Extrapleural Pneumonectomy [EPP]). Resected tissue or pleural fluid should be sent for pathological and histological evaluation. | All participants who had undergone surgery. | Posted | Number | participants | Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks) |
|
|
| ||||||||||||||||||||||||||
| Secondary | The 1 and 2 Year Disease-Free Survival Rate (Percentage) | Kaplan-Meier estimates of the percentage of participants still alive at 1-year and 2-years, based upon the total number of participants who had surgery. | All participants who had undergone surgery. | Posted | Mean | 95% Confidence Interval | percentage of participants | 1 year and 2 years |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Tumor Response | The frequency of best overall tumor response summarized by response category. The best (unconfirmed) response recorded from the start of chemotherapy treatment until disease progression/recurrence, start of any further anti-tumor therapy, or time of surgery whichever comes first. | Intention to Treat analysis. All enrolled participants who were eligible for the treatment, whether or not they received the study drug. | Posted | Number | participants | baseline to measured progressive disease |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure | Time to relapse (treatment failure) is measured in months and calculated as (Date of first surgery - Date of first relapse after surgery + 1)/(365.25/12). Time to relapse will be censored at the date of the last visit or start date of further anti-tumor therapy or intervention, whichever comes first. | All participants who had undergone surgery. | Posted | Mean | Full Range | months | baseline to stopping treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Progressive Disease | Number of months between the first dose date and the date of first disease progression or death as a result of any cause, whichever comes first. | All participants who had undergone surgery. | Posted | Mean | Full Range | months | baseline to measured progressive disease |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival Time | Number of months between the first dose date and the date of death as a result of any cause. Overall survival time calculated as (Date of death - First dose date + 1)/(365.25/12). | All participants who had undergone surgery. | Posted | Mean | Full Range | months | baseline to date of death from any cause |
|
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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 | Pemetrexed | pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 Gy | 15 | 77 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 10 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 10 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 10 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 10 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 10 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 10 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 10 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 10 | Systematic Assessment |
| |
| Abdominal distention | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 10 | Systematic Assessment |
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| Pain | General disorders | MedDRA 10 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 10 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 10 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 10 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 10 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 10 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10 | Systematic Assessment |
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| Neuropathy | Nervous system disorders | MedDRA 10 | Systematic Assessment |
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| Parosmia | Nervous system disorders | MedDRA 10 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 10 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 10 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Stage II |
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| Stage III |
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| Stage IV |
|
| Unknown/Not Available |
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| 2 - In bed < 50% of time |
|
| Sarcomatoid Mesothelioma |
|
| Other |
|
| East/Southeast Asian |
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| Western Asian |
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| Hispanic |
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