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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA021115 | U.S. NIH Grant/Contract | View source | |
| E8200 [ECOG] | Other Identifier | Eastern Cooperative Oncology Group (ECOG) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying giving irinotecan and docetaxel together with cetuximab to see how well it works compared to irinotecan and docetaxel alone in treating patients with metastatic pancreatic cancer .
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Courses repeat in both arms every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 1 year, and then periodically thereafter.
PROJECTED ACCRUAL: A total of 92 patients (46 per treatment arm)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irinotecan/Docetaxel | Active Comparator | Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m². Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles. |
|
| Irinotecan/Docetaxel/Cetuximab | Experimental | Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute. On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m². Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cetuximab | Biological | Patients received cetuximab intravenous infusions, via infusion pump or syringe pump, once a week for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Objective Response Evaluated by RECIST (Solid Tumor Response Criteria) | Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR | Assessed every 12 weeks until progression |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival was defined as the shorter of:
Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions. |
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Inclusion Criteria:
Histologically confirmed metastatic adenocarcinoma of the pancreas
Sufficient tumor tissue from fine needle aspiration, core biopsy, or open biopsy available for epidermal growth factor receptor testing
At least 1 unidimensionally measurable primary or metastatic lesionge
Age of 18 and over
ECOG performance status 0-1
Negative pregnancy test
Fertile patients must use effective contraception
Creatinine clearance > 60 mL/min
LVEF normal
Absolute neutrophil count > 1,500/mm^3
Platelet count > 100,000/mm^3
Bilirubin ≤ upper limit of normal (ULN)*
SGOT or SGPT and alkaline phosphatase must meet the criteria for 1 of the following*:
NOTE: *Percutaneous stenting or endoscopic retrograde cholangiopancreatography may be used to normalize liver function tests
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara A. Burtness, MD | Fox Chase Cancer Center | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Burtness BA, Powell ME, Berlin JD, et al.: Phase II ECOG trial of irinotecan/docetaxel with or without cetuximab in metastatic pancreatic cancer: updated survival and CA19-9 results. [Abstract] J Clin Oncol 26 (Suppl 15): A-4642, 2008. | ||
| Result | Burtness BA, Powell M, Berlin J, et al.: Phase II trial of irinotecan/docetaxel for advanced pancreatic cancer with randomization between irinotecan/docetaxel and irinotecan/docetaxel plus C225, a monoclonal antibody to the epidermal growth factor receptor (EGF-r) : Eastern Cooperative Oncology. [Abstract] J Clin Oncol 25 (Suppl 18): A-4519, 2007. |
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E8200 opened to accrual on 7/31/2003, accrued its first patient on 12/9/2003, and was suspended on 12/2/2004 for evaluation of response and toxicity. Arm B was reactivated on 7/12/2005 after meeting the response criteria; Arm A was reactivated on 11/23/2005. Arm B and Arm A closed to accrual on 4/17/2006 and 8/23/2006, respectively, after meeting the accrual goal.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Irinotecan/Docetaxel | Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m². Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles. |
| FG001 | Arm B: Irinotecan/Docetaxel/Cetuximab | Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute. On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m². Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Irinotecan/Docetaxel | Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m². Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of eligible patients who began treatment. |
| 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 | Proportion of Patients With Objective Response Evaluated by RECIST (Solid Tumor Response Criteria) | Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR | Eligible patients who began treatment were included in the analysis. | Posted | Number | 90% Confidence Interval | Proportion of participants | Assessed every 12 weeks until progression |
|
Assessed every 6 weeks while on treatment and for 30 days after the end 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 | Arm A: Irinotecan/Docetaxel | Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m². Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction | Immune system disorders | CTCAE (2.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | ECOG Statistical Office | 617-632-3012 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D000077143 | Docetaxel |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| docetaxel | Drug | Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Docetaxel was diluted in 100-150 ml of infusion solution. |
|
|
| irinotecan hydrochloride | Drug | After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. |
|
|
| Assessed every 3 months for 2 years and then every 6 months for 1 year |
| Overall Survival | Overall survival was defined as time from registration to death from any cause. | Assessed every 3 months for 2 years and then every 6 months for 1 year |
| Epidermal Growth Factor Receptor (EGFR) Status | EGFR expression was be evaluated by staining 5-micron paraffin sections of tumor biopsies with anti-EGFR clone 2-18C9 (DAKO Corporation, Carpinteria, CA) using an indirect immunoperoxidase technique according to the instructions provided by DAKO. In brief, this includes an antigen retrieval pretreatment, the blocking of endogenous peroxidase activity, incubation with anti-EGFR antibody or a negative reagent control, staining with a detection system, visualization, and coverslipping. | Original tumor tissue samples submitted within one month of patient randomization |
| Proportion of Patients With Thromboembolic Events | To determine the rate of thromboembolic events in this population when prophylactic enoxaparin sodium is administered. | Assessed every 6 weeks while on treatment and for 30 days after the end of treatment |
| Withdrawal by Subject |
|
| Other disease |
|
| Ineligible |
|
| Deterioration of health |
|
| QOL diminished |
|
| Rising ca 19-9 |
|
| Patient non-compliance |
|
| Still on treatment |
|
| Treatment break > 4 weeks |
|
| Did not start treatment |
|
| BG001 | Arm B: Irinotecan/Docetaxel/Cetuximab | Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute. On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m². Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks. |
| BG002 | Total | Total of all reporting groups |
| Median |
| Full Range |
| years |
|
| Sex: Female, Male | Gender of eligible patients who began treatment. | Count of Participants | Participants |
|
| OG001 | Arm B: Irinotecan/Docetaxel/Cetuximab | Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute. On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m². Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks. |
|
|
| Secondary | Progression-free Survival | Progression-free survival was defined as the shorter of:
Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions. | Eligible patients who began treatment. | Posted | Median | 90% Confidence Interval | months | Assessed every 3 months for 2 years and then every 6 months for 1 year |
|
|
|
| Secondary | Overall Survival | Overall survival was defined as time from registration to death from any cause. | Eligible patients who began treatment. | Posted | Median | 90% Confidence Interval | months | Assessed every 3 months for 2 years and then every 6 months for 1 year |
|
|
|
| Secondary | Epidermal Growth Factor Receptor (EGFR) Status | EGFR expression was be evaluated by staining 5-micron paraffin sections of tumor biopsies with anti-EGFR clone 2-18C9 (DAKO Corporation, Carpinteria, CA) using an indirect immunoperoxidase technique according to the instructions provided by DAKO. In brief, this includes an antigen retrieval pretreatment, the blocking of endogenous peroxidase activity, incubation with anti-EGFR antibody or a negative reagent control, staining with a detection system, visualization, and coverslipping. | Eligible and treated patients with EGFR stain results available. | Posted | Number | participants | Original tumor tissue samples submitted within one month of patient randomization |
|
|
|
| Secondary | Proportion of Patients With Thromboembolic Events | To determine the rate of thromboembolic events in this population when prophylactic enoxaparin sodium is administered. | Eligible and treated patients | Posted | Number | 90% Confidence Interval | Proportion of participants | Assessed every 6 weeks while on treatment and for 30 days after the end of treatment |
|
|
|
| 35 |
| 46 |
| 46 |
| 46 |
| EG001 | Arm B: Irinotecan/Docetaxel/Cetuximab | Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute. On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m². Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks. | 36 | 45 | 45 | 45 |
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Leukopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Lymphopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Neutropenia | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Transfusion: pRBCs | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Supraventricular Arrhythmias | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| Edema | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pericardial Effusion/Pericarditis | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| Thrombosis/Embolism | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Weight Loss | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| DIC (Disseminated Intravascular Coagulation) | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Rash/Desquamation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Skin-Other | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Ddhydration | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Diarrhea w/o Prior Colostomy | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| GI -Other | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Melena/GI Bleeding | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Alkaline Phosphatase Increased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Bilirubin Increased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| AST Increased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| ALT Increased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Infection w/ Grade 3 or 4 Neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Infection w/ Unknown ANC | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Infection w/o Neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Infection -Other | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dizziness/Lightheadedness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| Anxiety/Agitation | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| Neuropathy-Motor | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | CTCAE (2.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pain-Other | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Syndromes-Other | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Leukopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Neutropenia | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Thrombocytopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Edema | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Rigors/ Chills | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Weight Loss | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Nail Changes | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Rash/Desquamation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Skin-Other | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hot Flashes | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Mouth Dryness | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Taste Disturbance | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Diarrhea w/o Prior Colostomy | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Alkaline Phosphatase Increased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Bilirubin Increased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| AST Increased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| ALT Increased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Infection w/o Neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dizziness/Lightheadedness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| Neuropathy-Motor | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Neuropathy-Sensory | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Tearing | Eye disorders | CTCAE (2.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hiccoughs | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Creatinine Increased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |