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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01229 | |||
| CDR0000590335 | Registry Identifier | PDQ |
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RATIONALE: Drugs used in chemotherapy, such as floxuridine and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hepatic arterial infusion uses a catheter to carry cancer-killing substances directly into the liver. Radiolabeled monoclonal antibodies can find tumor cells and carry tumor-killing substances to them without harming normal cells. Giving hepatic arterial infusion of floxuridine together with gemcitabine hydrochloride and radiolabeled monoclonal antibody therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase I/II trial is studying the side effects and best dose of floxuridine when given as a hepatic arterial infusion together with gemcitabine hydrochloride and radiolabeled monoclonal antibody therapy and to see how well it works in treating liver metastases in patients with metastatic colorectal cancer.
OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) and associated toxicities of concurrent hepatic arterial infusion (HAI) fluorodeoxypyrimidine (FUdR)/Decadron and intravenous gemcitabine combined with intravenous yttrium-90 (^90Y) chimeric T84.66 (cT84.66) in colorectal cancer patients after hepatic resection or maximum surgical debulking (to < 3 cm) of liver metastases.
II. To study the feasibility and toxicities of such adjuvant therapy following resection and/or ablation of liver metastases.
III. To evaluate the biodistribution, clearance and metabolism of ^90Y and ^111In (indium-iii) chimeric T84.66 administered intravenously.
IV. To estimate radiation doses to whole body, normal organs, and tumor through serial nuclear imaging.
V. To correlate proteomic profiles pre and post-therapy with toxicities and anti-tumor effects.
OUTLINE: This is a phase I, dose-escalation study of floxuridine followed by a phase II study.
Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 and gemcitabine hydrochloride IV over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician.
After completion of study treatment, patients are followed up at 3 and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 and gemcitabine hydrochloride IV over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine hydrochloride | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Dose Limiting Toxicity | Dose Limiting Toxicity (DLT) defined as any treatment-related grade grade 3 nonhematologic toxicity not reversible to grade 2 or less within 24 hours, or any grade 4 toxicity.Up to three cycles of therapy were allowed with DLTs determined based on first cycle tolerance. Toxicity was graded using the National Cancer Institute Common Toxicity Criteria version 2.0. | 4 weeks from start of treatment, up to 2 years. |
| Recommended Phase II Dose | The maximum tolerated dose (MTD) of HAI FUdR in combination with intravenous gemcitabine and 90Y-DTPA-cT84.66 is based on toxicities observed during the first cycle and is defined as the highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Dose escalations proceeded according to a standard 3+3 design. | 4 weeks from start of treatment, up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause. | Up to 5 years |
| Progression-free Survival | Estimated using the product-limit method of Kaplan and Meier. Progression is defined as a 25% increase in the sum of products of measurable lesions over the smallest sum observed, or appearance of any lesions that had disappeared, or appearance of any new lesion/site. |
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Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Wong | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Level 1- FUdR 0.10 mg/kg/Day | Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (dose level 0.10 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2014 |
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| floxuridine | Drug | Given via hepatic arterial infusion |
|
|
| proteomic profiling | Genetic | Correlative studies |
|
| matrix-assisted laser desorption/ionization time of flight mass spectrometry | Other | Correlative studies |
|
|
| liquid chromatography | Other | Correlative studies |
|
|
| yttrium Y 90 anti-CEA monoclonal antibody cT84.66 | Radiation | Given IV |
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| mass spectrometry | Other | Correlative studies |
|
| pharmacological study | Other | Correlative studies |
|
|
| Up to 5 years |
| FG001 | Dose Level 2 - FUdR 0.15 mg/kg/Day | Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (dose level 0.15 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician. |
| FG002 | Dose Level 3 - FUdR 0.20 mg/kg/Day | Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (dose level 0.20 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level 1 - FUdR 0.10 mg/kg/Day | Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (starting dose level 0.10 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician. |
| BG001 | Dose Level 2 - FUdR 0.15 mg/kg/Day | Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (starting dose level 0.15 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician. |
| BG002 | Dose Level 3 - FUdR 0.20 mg/kg/Day | Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (starting dose level 0.20 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Karnofsky Performance Status for Assessment of Functional Impairment | 100 - Normal no complaints. 90 - Able to carry on normal activity; minor signs or symptoms of disease.80 - Normal activity with effort. 70 - Cares for self; unable to carry on normal activity or active work. 60 - Requires occasional assistance, but is able to care for most personal needs. 50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospitalization indicated although death not imminent. 20 - Very sick. Hospitalization necessary. Active supportive treatment necessary.10 - Moribund. 0 - Dead. | Median | Full Range | units on a scale |
|
| 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 | Number of Participants With at Least One Dose Limiting Toxicity | Dose Limiting Toxicity (DLT) defined as any treatment-related grade grade 3 nonhematologic toxicity not reversible to grade 2 or less within 24 hours, or any grade 4 toxicity.Up to three cycles of therapy were allowed with DLTs determined based on first cycle tolerance. Toxicity was graded using the National Cancer Institute Common Toxicity Criteria version 2.0. | All patients receiving treatment were evaluated for DLT. | Posted | Number | participants with DLTs | 4 weeks from start of treatment, up to 2 years. |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Recommended Phase II Dose | The maximum tolerated dose (MTD) of HAI FUdR in combination with intravenous gemcitabine and 90Y-DTPA-cT84.66 is based on toxicities observed during the first cycle and is defined as the highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Dose escalations proceeded according to a standard 3+3 design. | All patients observed for 56 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced. | Posted | Number | mg/kg/day | 4 weeks from start of treatment, up to 2 years. |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause. | Posted | Median | 95% Confidence Interval | Months | Up to 5 years |
| ||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Estimated using the product-limit method of Kaplan and Meier. Progression is defined as a 25% increase in the sum of products of measurable lesions over the smallest sum observed, or appearance of any lesions that had disappeared, or appearance of any new lesion/site. | Posted | Median | 95% Confidence Interval | Months | Up to 5 years |
|
Adverse events were collected over a period of 6 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to 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 | Dose Level 1- FUdR 0.10 mg/kg/Day | Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (starting dose level 0.10 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician. | 2 | 3 | 0 | 3 | 3 | 3 |
| EG001 | Dose Level 2- FUdR 0.15 mg/kg/Day | Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (starting dose level 0.15 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician. | 3 | 3 | 1 | 3 | 3 | 3 |
| EG002 | Dose Level 3- FUdR 0.20 mg/kg/Day | Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (starting dose level 0.20 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician. | 8 | 10 | 2 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Fever | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Treatment related secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra10.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | meddra9.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | meddra10.0 | Non-systematic Assessment |
| |
| Premature ventricular contractions | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | meddra9.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Anal pain | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Esophageal pain | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Oral hemorrhage | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Chills | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Edema limbs | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Fever | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Localized edema | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pain | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | meddra9.0 | Non-systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | meddra10.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Bilirubin increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Haptoglobin decreased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Hyperbilirubinemia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Hypercholesterolemia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Leukocyte count decreased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Leukopenia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Serum cholesterol increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Weight gain | Investigations | meddra9.0 | Non-systematic Assessment |
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| Weight loss | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Blood bicarbonate decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Serum albumin decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum calcium increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum glucose decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum magnesium decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum sodium increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum triglycerides increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Taste alteration | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Renal hemorrhage | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Urine discoloration | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | meddra9.0 | Non-systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hiccough | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hand-and-foot syndrome | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemorrhage | Vascular disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | meddra9.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Frankel, Ph.D. | City of Hope | 626-218-5265 | pfrankel@coh.org |
| Dec 21, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D005467 | Floxuridine |
| D002853 | Chromatography, Liquid |
| D013058 | Mass Spectrometry |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003857 | Deoxyuridine |
| D014529 | Uridine |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D002845 | Chromatography |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Male |
|
| Hispanic |
|
| Caucasian |
|
| Unknown |
|
| Participants |
|
|
| OG002 |
| Dose Level 3 - FUdR 0.20 mg/kg/Day |
Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (dose level 0.20 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician. |
|
|
| OG002 | Dose Level 3 - FUdR 0.20 mg/kg/Day | Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 (dose level 0.20 mg/kg/day) and gemcitabine hydrochloride IV (105 mg/m^2) over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV (16.6 mCi/m^2) over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician. |
|
|