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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-PL-S051 | Other Identifier | Eli Lilly and Company |
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The main purpose of this study of pemetrexed combined with cisplatin used as neoadjuvant chemotherapy (2 or 3 cycles) in participants with operable non-small cell lung cancer (NSCLC) is to look at various genes present in participants' blood and tumor tissue to see if there is any link between the levels or changes in the genes and how participants with lung cancer respond to pemetrexed and cisplatin treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemetrexed + Cisplatin | Experimental | Pemetrexed: 500 milligrams per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | 500 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs |
|
| Measure | Description | Time Frame |
|---|---|---|
| High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood | Molecular markers assessed by immunohistochemistry: thymidylate synthase, glycinamide ribonucleotide formyl transferase (GARFT), epidermal growth factor receptor (EGFR); and by polymerase chain reaction: dihydrofolate reductase (DHFR), dihydropyrimidine dehydrogenase (DPD), folylpolyglutamate synthetase (FPGS), reduced folate carrier, alpha folate receptor, Excision Repair Cross-Complementation Group 1 (ERCC1), folylpolyglutamate hydrolase (FPGH). Hypermethylated genes assessed by methylation-specific polymerase chain reaction. Due to small sample size, tumor-tissue analyses were not done. | Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Tumor Response (Response Rate) | Tumor response to treatment using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Response rate was estimated as the total number of CR or PR, divided by the total number of participants treated. |
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Inclusion Criteria:
Exclusion 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. | Bystra | 43-360 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed + Cisplatin | Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs. Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed + Cisplatin | Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs. Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood | Molecular markers assessed by immunohistochemistry: thymidylate synthase, glycinamide ribonucleotide formyl transferase (GARFT), epidermal growth factor receptor (EGFR); and by polymerase chain reaction: dihydrofolate reductase (DHFR), dihydropyrimidine dehydrogenase (DPD), folylpolyglutamate synthetase (FPGS), reduced folate carrier, alpha folate receptor, Excision Repair Cross-Complementation Group 1 (ERCC1), folylpolyglutamate hydrolase (FPGH). Hypermethylated genes assessed by methylation-specific polymerase chain reaction. Due to small sample size, tumor-tissue analyses were not done. | Due to lack of eligible participants, enrollment was stopped early when 30 participants were enrolled. Tumor samples were collected in only 19 of these 30 participants. Results obtained from analyses of a small number of available samples were considered to be of little scientific and medical relevance, and tumor-tissue analyses were not conducted. | Posted | Number | participants | Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed) |
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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 + Cisplatin | Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs. Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
Trial enrollment was terminated early due to lack of eligible participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| cisplatin | Drug | 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs |
|
| Radical Non-Small Cell Lung Cancer (NSCLC) surgery | Procedure | All participants proceeded to surgery within 4-8 weeks from the last dose of pemetrexed. |
|
| Treatment start to disease progression or surgery (4-8 weeks after last dose of pemetrexed) |
| Duration of Response | The duration of response was defined as the time from complete response (CR) or partial response (PR) to disease progression. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions. | Time of response to disease progression (up to 44.4 months) |
| Disease Free Survival (DFS) | DFS was the time from date of first dose to first observation of progressive disease (PD) or death due to any cause. PD=20% increase in sum of longest diameter of target lesions. If a participant was not known to have died or have PD, DFS was censored at the date of the last objective progression-free disease assessment. | Treatment start to disease progression or death from any cause (up to 45.5 months) |
| Overall Survival (OS) | OS was defined as the time from treatment start to death from any cause. For participants who were alive, OS was censored at the last contact date. | Treatment start to death from any cause (up to 47.6 months) |
| Poland |
| 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. | Poznan | 60-569 | Poland |
| 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. | Warsaw | 02-781 | Poland |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Basis for Diagnosis | Number | participants |
|
| Initial Pathological Diagnosis | Pemetrexed was approved in April 2008 for first- and second-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), other than predominantly squamous. Of the 30 participants enrolled at that time, 20 had squamous cell histology. The protocol was not amended since enrollment stopped early (October 2008) due to lack of eligible participants. | Number | participants |
|
| Stage of Disease at Study Entry | Tumor stages ranged from 0 (not spread) to IV (spread throughout the body). Stage IB=tumor was larger or grew deeper than IA, but was not in the lymph nodes; Stage IIA=cancer spread to some lymph nodes near the original tumor; Stage IIB=cancer was not in the lymph nodes but in the chest wall region, or was a larger tumor in the lymph nodes. | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Pemetrexed + Cisplatin | Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs. Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs. |
|
| Secondary | Percentage of Participants With Objective Tumor Response (Response Rate) | Tumor response to treatment using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Response rate was estimated as the total number of CR or PR, divided by the total number of participants treated. | Tumor response rate and 95% confidence interval (CI) of best CR or PR were evaluated on all qualified enrolled participants treated with at least 1 dose of study medication. Criteria=histological or cytological diagnosis of non-small cell lung cancer (NSCLC) IB-IIIA; presence of measurable disease; no previous NSCLC chemotherapy and radiotherapy. | Posted | Number | 95% Confidence Interval | percentage of participants | Treatment start to disease progression or surgery (4-8 weeks after last dose of pemetrexed) |
|
|
|
| Secondary | Duration of Response | The duration of response was defined as the time from complete response (CR) or partial response (PR) to disease progression. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions. | Duration of response was analyzed on responders treated with at least 1 dose of study medication. Criteria=histological or cytological diagnosis of non-small cell lung cancer (NSCLC) IB-IIIA; presence of measurable disease; no previous NSCLC chemotherapy and radiotherapy; responder. | Posted | Median | 95% Confidence Interval | months | Time of response to disease progression (up to 44.4 months) |
|
|
|
| Secondary | Disease Free Survival (DFS) | DFS was the time from date of first dose to first observation of progressive disease (PD) or death due to any cause. PD=20% increase in sum of longest diameter of target lesions. If a participant was not known to have died or have PD, DFS was censored at the date of the last objective progression-free disease assessment. | DFS was evaluated on all qualified enrolled patients who received at least 1 dose of study medication. Criteria=histological or cytological diagnosis of non-small cell lung cancer (NSCLC) IB-IIIA; presence of measurable disease; no previous NSCLC chemotherapy and radiotherapy. | Posted | Median | 95% Confidence Interval | months | Treatment start to disease progression or death from any cause (up to 45.5 months) |
|
|
|
| Secondary | Overall Survival (OS) | OS was defined as the time from treatment start to death from any cause. For participants who were alive, OS was censored at the last contact date. | OS was evaluated on all qualified enrolled patients who received at least 1 dose of study medication. | Posted | Median | 95% Confidence Interval | months | Treatment start to death from any cause (up to 47.6 months) |
|
|
|
| 4 |
| 30 |
| 19 |
| 30 |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Bronchopleural fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| 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 |