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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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The purpose of this study is to determine disease response of GEMOX-Panitumumab (GEMOX-P) in KRAS/ BRAF wild-type, Stage IV, biliary tract and gallbladder cancer patients who have previously not received chemotherapy. This study will also examine the potential toxicities, progression-free and overall survival in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panitumumab | Experimental | Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab | Drug | Day 1 and 15 = 6 mg/kg IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Response to GEMOX-Panitumumab (GEMOX-P) in Chemotherapy naïve KRAS/ BRAF Wild Type Stage IV Biliary Tract Cancer Using the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria. | Tumor measurement - same imaging modality used in pre-treatment evaluation - include radiological examination of all areas with affected disease. For pretreatment and at the end of cycle 2 CT scans (chest/abdomen/pelvis) will be used. For all subsequent cycles, CT of chest/abdomen/pelvis will be used every 8 weeks. | end of cycle 2 of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression Free Survival | Progression-free survival was defined as the time from study enrollment to date of cancer progression or death, whichever occurred first. Progression was assessed using CT scans and the Response Evaluation Criteria In Solid Tumors criteria. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aram Hezel, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber / Harvard Cancer Center | Boston | Massachusetts | 02215 | United States | ||
| University of Rochester Medical Center |
5 subjects were not eligible to enroll. 2 participants did not receive the intervention.
38 participants were screened.
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| ID | Title | Description |
|---|---|---|
| FG000 | Panitumumab | Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days) Panitumumab: Day 1 and 15 = 6 mg/kg IV oxaliplatin: Days 1 and 15 = 85mg/m2 IV gemcitabine: Days 1 and 15 = 1000 mg/m2 IV |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Panitumumab | Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days) Panitumumab: Day 1 and 15 = 6 mg/kg IV oxaliplatin: Days 1 and 15 = 85mg/m2 IV gemcitabine: Days 1 and 15 = 1000 mg/m2 IV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | The Number of Participants With Response to GEMOX-Panitumumab (GEMOX-P) in Chemotherapy naïve KRAS/ BRAF Wild Type Stage IV Biliary Tract Cancer Using the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria. | Tumor measurement - same imaging modality used in pre-treatment evaluation - include radiological examination of all areas with affected disease. For pretreatment and at the end of cycle 2 CT scans (chest/abdomen/pelvis) will be used. For all subsequent cycles, CT of chest/abdomen/pelvis will be used every 8 weeks. | Posted | Number | participants | end of cycle 2 of treatment |
|
Adverse events were collected for the duration of treatment.
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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 | Panitumumab | Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days) Panitumumab: Day 1 and 15 = 6 mg/kg IV oxaliplatin: Days 1 and 15 = 85mg/m2 IV gemcitabine: Days 1 and 15 = 1000 mg/m2 IV |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aram F Hezel | University of Rochester | 585-275-5823 | aram_hezel@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D005706 | Gallbladder Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
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| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| D000077150 | Oxaliplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| oxaliplatin | Drug | Days 1 and 15 = 85mg/m2 IV |
|
| gemcitabine | Drug | Days 1 and 15 = 1000 mg/m2 IV |
|
| time to cancer progression or death |
| Median Overall Survival | Death from any cause was used. | enrollment until date of death |
| The Number of Participants Who Experience an Adverse Event | Any adverse event continuing after the study completion and considered potentially related to study treatment will be followed until resolution, stabilization or initiation of treatment that confounds the ability to assess the event | baseline to study completion |
| Rochester |
| New York |
| 14642 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance status | ECOG describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. It ranges from 0-5 with higher numbers indicating reduced ability to care for themself. | Number | participants |
|
| Extent of disease | Number | participants |
|
| primary tumor site | Number | participants |
|
| metastases | Number | participants |
|
|
|
| Secondary | Median Progression Free Survival | Progression-free survival was defined as the time from study enrollment to date of cancer progression or death, whichever occurred first. Progression was assessed using CT scans and the Response Evaluation Criteria In Solid Tumors criteria. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Posted | Median | Full Range | months | time to cancer progression or death |
|
|
|
| Secondary | Median Overall Survival | Death from any cause was used. | Posted | Median | Full Range | months | enrollment until date of death |
|
|
|
| Secondary | The Number of Participants Who Experience an Adverse Event | Any adverse event continuing after the study completion and considered potentially related to study treatment will be followed until resolution, stabilization or initiation of treatment that confounds the ability to assess the event | Posted | Number | participants | baseline to study completion |
|
|
|
| 0 |
| 31 |
| 31 |
| 31 |
| neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| elevated alkaline phosphatase | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypomagnesemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D005705 | Gallbladder Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |