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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-MC-S077 |
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The purpose of this study is to help answer the following research questions:
If the study drug Pemetrexed can help patients with rectal cancer; If molecular biological parameters are correlated respectively changing due to cytotoxic treatment with Pemetrexed; To evaluate adverse events
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | 500 mg/m2, intravenous (IV), every 21 days x 3 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Pemetrexed Prior to Surgery | Feasibility was defined as the ability to receive the total planned dose of Pemetrexed administered over a period of no more than 9 weeks permitting scheduling conflict. A ±5 percent variance in the calculated total dose was allowed. | 3 cycles (21-day cycles) |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response (pCR) | Pathological complete response was defined as the absence of any tumor cells. | surgery following 3 cycles (21-day cycles) of chemotherapy |
| Number of Participants With Complete Tumor Resection |
Not provided
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 - 5PM 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. | Gothenburg | 41685 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed | 500 mg/m2, intravenous (IV), every 21 days x 3 cycles |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed | 500 mg/m2, intravenous (IV), every 21 days x 3 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 | Feasibility of Pemetrexed Prior to Surgery | Feasibility was defined as the ability to receive the total planned dose of Pemetrexed administered over a period of no more than 9 weeks permitting scheduling conflict. A ±5 percent variance in the calculated total dose was allowed. | Number of participants enrolled. | Posted | Number | participants | 3 cycles (21-day cycles) |
|
|
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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 | 500 mg/m2, intravenous (IV), every 21 days x 3 cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 9.1 | 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 |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| surgery following 3 cycles (21-day cycles) of chemotherapy |
| Number of Participants Receiving Sphincter Saving Surgery | surgery following 3 cycles (21-day cycles) of chemotherapy |
| Sweden |
| 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 | participants |
|
| Histopathological Diagnosis | Assesses the extent to which cancer cells are similar in appearance and function to healthy cells of the same tissue type. Grades range from 1 (least aggressive and best prognosis) to 4 (most aggressive and worst prognosis). | Number | participants |
|
| Race/Ethnicity | Number | participants |
|
| Blood Pressure | Mean | Standard Deviation | mm Hg |
|
| Body Height | Mean | Standard Deviation | centimeters |
|
| Body Surface Area | BSA is derived as ((height[cm] x weight[kg])/3600)1/2 | Mean | Standard Deviation | meter squared |
|
| Body Weight | Mean | Standard Deviation | kilograms |
|
| Heart Rate | Mean | Standard Deviation | beats per minute |
|
| Time Since Initial Pathological Diagnosis | One patient is excluded because his pathological diagnosis occured 3.6 weeks after the date of informed consent. | Mean | Standard Deviation | weeks |
|
|
| Secondary | Pathological Complete Response (pCR) | Pathological complete response was defined as the absence of any tumor cells. | Number of participants enrolled. | Posted | Number | participants | surgery following 3 cycles (21-day cycles) of chemotherapy |
|
|
|
| Secondary | Number of Participants With Complete Tumor Resection | Number of participants enrolled. | Posted | Number | participants | surgery following 3 cycles (21-day cycles) of chemotherapy |
|
|
|
| Secondary | Number of Participants Receiving Sphincter Saving Surgery | Number of participants enrolled. | Posted | Number | participants | surgery following 3 cycles (21-day cycles) of chemotherapy |
|
|
|
| 17 |
| 37 |
| Myocardial ischaemia | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Anorectal infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Peritoneal abscess | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 9.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
|
| Buttock pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal 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 |
|