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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-FP-S057 | Other Identifier | Eli Lilly and Company |
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A non-randomized phase II study to determine the efficacy and safety of the combination of Pemetrexed and Irinotecan every two weeks in metastatic colorectal cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemetrexed + Irinotecan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | 400 mg/m^2, intravenous (IV), every 14 days x 12 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Tumor Response | Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria. | baseline to measured progressive disease (up to 2 years follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. |
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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. | Angers | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20396391 | Result | Louvet C, Andre T, Gamelin E, Hebbar M, Mabro M, Bennamoun M, Rassam H, de Gramont A. Phase II Study of Biweekly Pemetrexed Plus Irinotecan as Second-Line Therapy for Metastatic Colorectal Cancer. J Oncol. 2010;2010:785934. doi: 10.1155/2010/785934. Epub 2010 Apr 8. |
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Two participants discontinued the trial before receiving study treatment. One due to entry criteria exclusion and one due to withdrawal by subject. Therefore, 44 participants received at least one dose of chemotherapy and are included in the efficacy and safety analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed + Irinotecan | Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed + Irinotecan | Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles |
| 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 | Best Overall Tumor Response | Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria. | All enrolled participants with at least one completed cycle. | Posted | Number | participants | baseline to measured progressive disease (up to 2 years follow-up) |
|
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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 + Irinotecan | Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 7.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 7.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| irinotecan | Drug | 180 mg/m^2, intravenous (IV), every 14 days x 12 cycles |
|
| time of response to progressive disease or death (up to 2 years follow-up) |
| Progression-Free Survival (PFS) | Defined as the time from study enrollment to the first date of disease progression or death as a result of any cause. PFS was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed. | baseline to measured progressive disease or death (up to 2 years follow-up) |
| Time to Treatment Failure | Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed. | baseline to stopping treatment (up to 2 years follow-up) |
| Overall Survival | Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. | baseline to date of death from any cause (up to 2 years follow-up) |
| 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. | Lille | France |
| 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. | Montfermeil | France |
| 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. | Paris | France |
| 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. | Suresnes | France |
| Entry Criteria Exclusion |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). | Number | units on a scale |
|
| Pathological Diagnosis | Number | participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
|
|
| Secondary | Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. | All enrolled participants with at least completed cycle and who had a complete or partial response. | Posted | Median | 95% Confidence Interval | days | time of response to progressive disease or death (up to 2 years follow-up) |
|
|
|
| Secondary | Progression-Free Survival (PFS) | Defined as the time from study enrollment to the first date of disease progression or death as a result of any cause. PFS was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed. | All enrolled participants with at least one completed cycle. | Posted | Median | 95% Confidence Interval | days | baseline to measured progressive disease or death (up to 2 years follow-up) |
|
|
|
| Secondary | Time to Treatment Failure | Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed. | All enrolled participants with at least one completed cycle. | Posted | Median | 95% Confidence Interval | days | baseline to stopping treatment (up to 2 years follow-up) |
|
|
|
| Secondary | Overall Survival | Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. | All enrolled participants with at least one completed cycle. | Posted | Median | 95% Confidence Interval | days | baseline to date of death from any cause (up to 2 years follow-up) |
|
|
|
| 13 |
| 38 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 7.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 7.0 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA 7.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 7.0 | Systematic Assessment |
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| Hepatic pain | Hepatobiliary disorders | MedDRA 7.0 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 7.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 7.0 | Systematic Assessment |
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| Diabetes mellitus insulin-dependent | Metabolism and nutrition disorders | MedDRA 7.0 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA 7.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 7.0 | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA 7.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 7.0 | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA 7.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 7.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 7.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 7.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 7.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 7.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 7.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 7.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal 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 |
| D002166 | Camptothecin |
| D000470 | Alkaloids |