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This study evaluates the combination chemotherapy with gemcitabine, irinotecan and panitumumab in patients with advanced biliary cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy | Experimental | Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine, Irinotecan, Panitumumab | Drug | Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival Rate at Five Months | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate From Combination Chemotherapy | 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Giantonia, MD | Abramson CC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center at University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24146220 | Derived | Sohal DP, Mykulowycz K, Uehara T, Teitelbaum UR, Damjanov N, Giantonio BJ, Carberry M, Wissel P, Jacobs-Small M, O'Dwyer PJ, Sepulveda A, Sun W. A phase II trial of gemcitabine, irinotecan and panitumumab in advanced cholangiocarcinoma. Ann Oncol. 2013 Dec;24(12):3061-5. doi: 10.1093/annonc/mdt416. Epub 2013 Oct 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy | Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities. Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy | Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities. Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities. |
| 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 | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Progression Free Survival Rate at Five Months | Posted | Number | percentage of participants | 5 months |
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| Secondary | Response Rate From Combination Chemotherapy | Posted | Count of Participants | Participants | 5 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 | Chemotherapy | Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities. Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities. | 21 | 35 | 35 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrhythmia | Cardiac disorders |
| |||
| Fatigue | General disorders |
| |||
| Fever | General disorders |
| |||
| Respiratory Arrest | Respiratory, thoracic and mediastinal disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
| |||
| Dehydration | Gastrointestinal disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Free Air | Gastrointestinal disorders |
| |||
| Obstruction, GI | Gastrointestinal disorders |
| |||
| Abdomen NOS | Infections and infestations |
| |||
| Febrile Neutropenia | Infections and infestations |
| |||
| Neurological Meningitis | Infections and infestations |
| |||
| Sepsis | Infections and infestations |
| |||
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e | Infections and infestations |
| |||
| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations |
| |||
| Infection with unknown ANC | Infections and infestations |
| |||
| Hyperbilirubinemia | Metabolism and nutrition disorders |
| |||
| Hypercalcemia | Metabolism and nutrition disorders |
| |||
| Hypomagnesemia | Metabolism and nutrition disorders |
| |||
| Confusion | Nervous system disorders |
| |||
| Encephalopathy | Nervous system disorders |
| |||
| Syncope (fainting) | Nervous system disorders |
| |||
| Pain | General disorders |
| |||
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| chronic obstructive pulmonary disease | Reproductive system and breast disorders |
| |||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders |
| |||
| Renal Failure | Renal and urinary disorders |
| |||
| Peripheral arterial ischemia | Vascular disorders |
| |||
| Thrombosis/thombus/embolism | Vascular disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bloating | Gastrointestinal disorders |
| |||
| abdominal cramping | Gastrointestinal disorders |
| |||
| abdominal fullness | Gastrointestinal disorders |
| |||
| abdominal pain | Gastrointestinal disorders |
| |||
| acidosis | Metabolism and nutrition disorders |
| |||
| acne-form | Skin and subcutaneous tissue disorders |
| |||
| acute arterial occulsion LLE | Vascular disorders |
| |||
| infusion reaction | General disorders |
| |||
| acute renal failure | Renal and urinary disorders |
| |||
| Hypoalbuminemia | Metabolism and nutrition disorders |
| |||
| alkaline phosphatase (high) | Metabolism and nutrition disorders |
| |||
| alkalosis | Metabolism and nutrition disorders |
| |||
| allergic rhinitis | Immune system disorders |
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| tape allergy | Immune system disorders |
| |||
| alopecia | Skin and subcutaneous tissue disorders |
| |||
| Alanine Aminotransferase (high) | Metabolism and nutrition disorders |
| |||
| amylase (high) | Metabolism and nutrition disorders |
| |||
| neutropenia | Blood and lymphatic system disorders |
| |||
| anorexia | Gastrointestinal disorders |
| |||
| anxiety | Psychiatric disorders |
| |||
| ascending cholangitis | Infections and infestations |
| |||
| ascites | Gastrointestinal disorders |
| |||
| Aspartate Aminotransferase (high) | Metabolism and nutrition disorders |
| |||
| atelectasis | Respiratory, thoracic and mediastinal disorders |
| |||
| edema | Blood and lymphatic system disorders |
| |||
| back pain | Musculoskeletal and connective tissue disorders |
| |||
| belching | Gastrointestinal disorders |
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| Metabolic Acidosis | Metabolism and nutrition disorders |
| |||
| bilirubin (high) | Metabolism and nutrition disorders |
| |||
| hemorrhoids | Vascular disorders |
| |||
| blurred vision | Eye disorders |
| |||
| Body Aches | Musculoskeletal and connective tissue disorders |
| |||
| low calcium | Metabolism and nutrition disorders |
| |||
| high calcium | Metabolism and nutrition disorders |
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| cellulitis | Infections and infestations |
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| cerebro-vascular ischemia | Nervous system disorders |
| |||
| cheliosis | Skin and subcutaneous tissue disorders |
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| Chills | General disorders |
| |||
| cold (respiratory) | Immune system disorders |
| |||
| confusion | Psychiatric disorders |
| |||
| congestion | Respiratory, thoracic and mediastinal disorders |
| |||
| conjuctivitis | Infections and infestations |
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| constipation | Gastrointestinal disorders |
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| contact dermatitis | Skin and subcutaneous tissue disorders |
| |||
| cough | Respiratory, thoracic and mediastinal disorders |
| |||
| high creatinine | Metabolism and nutrition disorders |
| |||
| decreased appetite | Gastrointestinal disorders |
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| dehydration | Gastrointestinal disorders |
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| dementia | Psychiatric disorders |
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| depression | Psychiatric disorders |
| |||
| dermal changes | Blood and lymphatic system disorders |
| |||
| diarrhea | Gastrointestinal disorders |
| |||
| dizziness | General disorders |
| |||
| dry cough | Respiratory, thoracic and mediastinal disorders |
| |||
| dry eye | Eye disorders |
| |||
| dry mouth | Gastrointestinal disorders |
| |||
| dry skin | Skin and subcutaneous tissue disorders |
| |||
| dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| Dysgeusia | Gastrointestinal disorders |
| |||
| Dyspepsia | Gastrointestinal disorders |
| |||
| dysphagia | Gastrointestinal disorders |
| |||
| electrolyte imbalance | Metabolism and nutrition disorders |
| |||
| elevated LTF | Metabolism and nutrition disorders |
| |||
| epistaxis | Respiratory, thoracic and mediastinal disorders |
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| erectile dysfunction | Reproductive system and breast disorders |
| |||
| exostosis | Skin and subcutaneous tissue disorders |
| |||
| eye infection | Infections and infestations |
| |||
| fall | Injury, poisoning and procedural complications |
| |||
| fatigue | General disorders |
| |||
| febrile neutropenia | Infections and infestations |
| |||
| Fever | General disorders |
| |||
| flatulance | Gastrointestinal disorders |
| |||
| floater | Eye disorders |
| |||
| flu-like symptoms | General disorders |
| |||
| Flush | Vascular disorders |
| |||
| Foot pain | Musculoskeletal and connective tissue disorders |
| |||
| fracture | Musculoskeletal and connective tissue disorders |
| |||
| fungal infection | Infections and infestations |
| |||
| aches | General disorders |
| |||
| hypergylcemia | Metabolism and nutrition disorders |
| |||
| hypoglymcemia | Metabolism and nutrition disorders |
| |||
| carpal tunel | Musculoskeletal and connective tissue disorders |
| |||
| hand tremors | Nervous system disorders |
| |||
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders |
| |||
| headache | Nervous system disorders |
| |||
| heartburn | Gastrointestinal disorders |
| |||
| hematuria | Renal and urinary disorders |
| |||
| anemia | Blood and lymphatic system disorders |
| |||
| Hepatic Encephalopathy | Hepatobiliary disorders |
| |||
| herituism | Skin and subcutaneous tissue disorders |
| |||
| hiccups | Respiratory, thoracic and mediastinal disorders |
| |||
| hoarseness | Respiratory, thoracic and mediastinal disorders |
| |||
| hot flashes | Vascular disorders |
| |||
| Hyperesthesia | Musculoskeletal and connective tissue disorders |
| |||
| hypertension | Vascular disorders |
| |||
| hypertochosis | Skin and subcutaneous tissue disorders |
| |||
| hypokalemia | Metabolism and nutrition disorders |
| |||
| Hypomagnesemia | Metabolism and nutrition disorders |
| |||
| hypoxia | Respiratory, thoracic and mediastinal disorders |
| |||
| skin infection | Infections and infestations |
| |||
| sinus infection | Infections and infestations |
| |||
| finger infection | Infections and infestations |
| |||
| insomnia | Psychiatric disorders |
| |||
| itching | Skin and subcutaneous tissue disorders |
| |||
| IV infiltration | Skin and subcutaneous tissue disorders |
| |||
| karatoses | Skin and subcutaneous tissue disorders |
| |||
| kidney stone | Renal and urinary disorders |
| |||
| toe infection | Infections and infestations |
| |||
| leg cramps | Musculoskeletal and connective tissue disorders |
| |||
| leg ulceration | Skin and subcutaneous tissue disorders |
| |||
| Leukocytosis | Blood and lymphatic system disorders |
| |||
| light headedness | Nervous system disorders |
| |||
| loss of appetite | Metabolism and nutrition disorders |
| |||
| lymphopenia | Investigations |
| |||
| hypermagnesemia | Metabolism and nutrition disorders |
| |||
| mouth sores | Gastrointestinal disorders |
| |||
| mucositis | Gastrointestinal disorders |
| |||
| muscle cramping | Musculoskeletal and connective tissue disorders |
| |||
| nausea | Gastrointestinal disorders |
| |||
| neutropenic fever | Blood and lymphatic system disorders |
| |||
| Neutrophil count decreased | Investigations |
| |||
| night sweats | General disorders |
| |||
| numbness | Nervous system disorders |
| |||
| oral thrush | Infections and infestations |
| |||
| occular infection | Infections and infestations |
| |||
| hypertrichosis | Skin and subcutaneous tissue disorders |
| |||
| periorbital hair changes | Skin and subcutaneous tissue disorders |
| |||
| xerosis back | Skin and subcutaneous tissue disorders |
| |||
| buttock pain | Musculoskeletal and connective tissue disorders |
| |||
| chest pain | General disorders |
| |||
| Hepatic pain | Hepatobiliary disorders |
| |||
| Joint Pain | Musculoskeletal and connective tissue disorders |
| |||
| Ear Pain | Ear and labyrinth disorders |
| |||
| shoulder pain | Musculoskeletal and connective tissue disorders |
| |||
| Solar Plexis Pain | Nervous system disorders |
| |||
| forearm pain | Musculoskeletal and connective tissue disorders |
| |||
| Upper Quadrant Pain | Musculoskeletal and connective tissue disorders |
| |||
| Scapula pain | Musculoskeletal and connective tissue disorders |
| |||
| stent pain | Injury, poisoning and procedural complications |
| |||
| palpitations | Cardiac disorders |
| |||
| paronychia | Infections and infestations |
| |||
| Pulmonary Embolism | Vascular disorders |
| |||
| Pericardial effusion | Cardiac disorders |
| |||
| Hypophosphatemia | Metabolism and nutrition disorders |
| |||
| Platelet count decreased | Investigations |
| |||
| Pleural effusion | Reproductive system and breast disorders |
| |||
| pneumonia | Infections and infestations |
| |||
| poison ivy | Skin and subcutaneous tissue disorders |
| |||
| Hypokalemia | Metabolism and nutrition disorders |
| |||
| Pruritis | Skin and subcutaneous tissue disorders |
| |||
| Activated partial thromboplastin time prolonged | Investigations |
| |||
| rash | Skin and subcutaneous tissue disorders |
| |||
| rectal bleeding | Renal and urinary disorders |
| |||
| rectal fissure | Renal and urinary disorders |
| |||
| reflux | Gastrointestinal disorders |
| |||
| renal failure | Renal and urinary disorders |
| |||
| respiratory infection | Infections and infestations |
| |||
| rhinitis | Immune system disorders |
| |||
| rigors | General disorders |
| |||
| scratched cornea | Eye disorders |
| |||
| seasonal allergy | Immune system disorders |
| |||
| sepsis | Infections and infestations |
| |||
| septic shock | Infections and infestations |
| |||
| shortness of breath | Respiratory, thoracic and mediastinal disorders |
| |||
| sinus headache | Nervous system disorders |
| |||
| sinus tachcardia | Vascular disorders |
| |||
| sinusitus | Infections and infestations |
| |||
| small bowel obstruction | Gastrointestinal disorders |
| |||
| Hypernatremia | Metabolism and nutrition disorders |
| |||
| Hyponatremia | Metabolism and nutrition disorders |
| |||
| somnolence | Nervous system disorders |
| |||
| sore throat | Respiratory, thoracic and mediastinal disorders |
| |||
| sweating | General disorders |
| |||
| syncope | Nervous system disorders |
| |||
| taste alteration | Gastrointestinal disorders |
| |||
| deep vein thrombosis | Vascular disorders |
| |||
| thrombocytosis | Blood and lymphatic system disorders |
| |||
| thrombosis | Vascular disorders |
| |||
| thrush | Infections and infestations |
| |||
| trichomegaly | Skin and subcutaneous tissue disorders |
| |||
| Hypertriglyceridemia | Metabolism and nutrition disorders |
| |||
| upper respiratory congestion | Respiratory, thoracic and mediastinal disorders |
| |||
| upset stomach | Gastrointestinal disorders |
| |||
| urinary tract infection | Infections and infestations |
| |||
| vessel injury | Injury, poisoning and procedural complications |
| |||
| vomiting | Gastrointestinal disorders |
| |||
| weight loss | Investigations |
| |||
| yeast infection | Infections and infestations |
| |||
| Hyperkalemia | Metabolism and nutrition disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bruce Giantonio | Abramson Cancer Center | (215) 615-5858 | bruce.giantonio@uphs.upenn.edu |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077146 | Irinotecan |
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Complete Response |
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| Partial Response |
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| Stable Disease |
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| Progressive Disease |
| |||||
| Not Assessable |
|