Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Rare Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Cholangiocarcinoma

Bile Duct Neoplasms

Neoplastic Processes

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Hematinics

Irinotecan

Dexamethasone

Gemcitabine

Oxaliplatin

Dexamethasone acetate

Liver Extracts

Panitumumab

Floxuridine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antimetabolites

Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)

Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)

Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.

Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.

Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump

Hepatic artery infusion pump floxuridine and dexamethasone

Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)

Systemic chemotherapy for colorectal liver metastases

Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)

Systemic chemotherapy for intrahepatic cholangiocarcinoma

Michael J Cavnar, MD

Due to discontinuation of the Codman C3000 pump, an alternate device is necessary to continue serving patients in need of hepatic arterial infusion chemotherapy. This study aims to test the safety of hepatic artery infusion pump placement, a standard surgical procedure, and intraarterial chemotherapy initiation with the standard medication floxuridine (FUDR), using the Medtronic Synchromed II pump combined with the Codman arterial catheter in patients with unresectable (not removable by surgery) liver metastases from colorectal cancer and unresectable intrahepatic cholangiocarcinoma. This study will determine if complication and pump loss rates will be similar to previously published rates for the Codman system.

Patients with unresectable colorectal liver metastases (arm 1) and unresectable intrahepatic cholangiocarcinoma (arm 2), will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. All patients will receive hepatic artery infusion floxuridine, and then individual arms will receive disease-specific systemic chemotherapy.

Codman Catheter/Synchromed Pump Hepatic Artery Chemotherapy for Unresectable Colorectal Metastases/Intrahepatic Cholangiocarcinoma

Feasibility Pilot of Hepatic Arterial Infusion Chemotherapy in a Rural Catchment Area, Using the Codman Vascular Catheter With the Synchromed II Pump, for Patients With Unresectable Colorectal Cancer Liver Metastases or Unresectable Intrahepatic Cholangiocarcinoma

The percent of patients who complete the 1st cycle of hepatic artery chemotherapy will be tabulated. This is a conglomerate safety endpoint which is a surrogate for any complication that prevents delivery of hepatic artery chemotherapy via the device combination.

Tabulation of CTCAE serious adverse events attributed to pump implantation

Quantify the percent of patients with inability to meet primary outcome due to catheter disconnects.

Quantify the percent of patients with inability to meet primary outcome due to inability to access pump.

Percentage of patients who need secondary intervention (IR embolization, revision of pump or tubing) to achieve primary pump function.

Patients are screen using a psychosocial assessment tool for high risk of hepatic artery pump loss/failure, percent declined will be tabulated.

Percent of patients that experience pump loss/failure due to inability to attend scheduled followup appointments will be tabulated.

The number of staff contacts (phone calls) to assure patients keep their followup visits will be tabulated.

The percentage of patients who remain on pump chemotherapy at 3 months will be tabulated.

RECIST v1.1 will be used to assess overall response rate at 6 months.

The percent of patients who are downstaged and undergo surgery will be tabulated.

The percentage of patients who remain on pump chemotherapy at 6months will be tabulated.

Assistant Professor

Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)

Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.

Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump

Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)

Colorectal Liver Metastases

Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)

Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.

Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump

Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)

Total

40-70 years

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Michael Cavnar

Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy

30-day Postoperative Serious Adverse Events Related to Pump Implantation

30-day Catheter Malfunction Due to Tubing Disconnect

30-day Catheter Malfunction Due to Inability to Access Pump

Percent of Patients That Require Secondary Intervention in Order to Obtain Primary Pump Function.

Percent of Screened Patients That Are Declined Due to High Risk of Failure as Determined by the Psychosocial Assessment Tool.

Percent Pump Loss Due to Inability to Attend Scheduled Followup Appointments.

Number of Interventions (Phone Calls) to Assure Patients Attend Followup Appointments.

Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 3 Months.

At the 6 month time point for this outcome there were only 14 evaluable participants for response rate due to attrition, death, or sub-RECIST threshold disease.

Overall Response Rate at 6 Months

Percent of Patients Who Are Downstaged and Undergo Surgery

Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 6 Months.

Overall Study

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Pancrelipase

Pancreatin

On Day 1 of the treatment period, patients will undergo standard-of-care diagnostic laparoscopy to confirm the absence of metastatic disease not seen on staging imaging, as well as tissue acquisition (blood and liver biopsies) for pre-specified correlative scientific studies. On Day 2 (±1 day), patients will receive the interventional treatment, which is neoadjuvant HA chemotherapy. On Day 14 (±5 business days), patients will undergo standard-of-care resection of their primary tumor, as well as tissue acquisition (blood, liver biopsies, primary tumor, regional lymph nodes) for pre-specified correlative scientific studies.

HA Chemotherapy

Daniel Nussbaum, MD

Adi Molvin, BSN

Stacy Murray

This is a window-of-opportunity study which will evaluate the safety and feasibility of single-dose neoadjuvant Hepatic Artery (HA) chemotherapy (FUDR/oxaliplatin) in patients with localized pancreatic ductal adenocarcinoma (PDAC) eligible for surgical resection and systemic chemotherapy.

Current standard-of-care therapy for patients with localized PDAC includes surgical resection and six months of systemic chemotherapy. Because the sequence of these treatments (surgery and chemotherapy) is not well established, we will include both patients planned to undergo surgery before chemotherapy, as well as patients planned to receive systemic chemotherapy before surgery. This will allow us to test the safety and feasibility of adding single-dose neoadjuvant HA chemotherapy prior to surgery across the real-world treatment strategies employed in typical clinical practice. Moreover, the window-of-opportunity design is intended to make sure that all patients receive HA chemotherapy in addition to standard-of-care surgery and systemic chemotherapy, so as not to withhold the treatment approach currently associated with best outcomes.

The primary endpoint is safety and feasibility, and patients will be followed for 30 days after resection of their primary tumors to assess these outcomes. Following the short-term follow-up period, patients move to long-term follow-up, which will occur every three months after resection of the primary tumor, for a period of up to three years. Long-term secondary endpoints include disease free survival (DFS), liver metastasis-free survival (LMFS), and overall survival (OS).

This window-of-opportunity study will evaluate the safety and feasibility of single-dose neoadjuvant HA chemotherapy (FUDR/oxaliplatin) in patients with localized PDAC eligible for surgical resection and systemic chemotherapy. Current standard-of-care therapy for patients with localized PDAC includes surgical resection and six months of systemic chemotherapy. Because the sequence of these treatments (surgery and chemotherapy) is not well established, we will include both patients planned to undergo surgery before chemotherapy, as well as patients planned to receive systemic chemotherapy before surgery. This will allow us to test the safety and feasibility of adding single-dose neoadjuvant HA chemotherapy prior to surgery across the real-world treatment strategies employed in typical clinical practice. Moreover, the window-of-opportunity design is intended to make sure that all patients receive HA chemotherapy in addition to standard-of-care surgery and systemic chemotherapy, so as not to withhold the treatment approach currently associated with best outcomes.

During an initial screening period (0 to 28 days before the treatment period), informed consent will be obtained and all inclusion/exclusion criteria will be confirmed for participation. Once deemed appropriate for participation, patients will be enrolled and begin study treatment. On Day 1 of the treatment period, patients will undergo standard-of-care diagnostic laparoscopy to confirm the absence of metastatic disease not seen on staging imaging, as well as tissue acquisition (blood and liver biopsies) for pre-specified correlative scientific studies. On Day 2 (±1 day), patients will receive the interventional treatment, which is neoadjuvant HA chemotherapy. On Day 14 (±5 business days), patients will undergo standard-of-care resection of their primary tumor, as well as tissue acquisition (blood, liver biopsies, primary tumor, regional lymph nodes) for pre-specified correlative scientific studies.

The primary endpoint is safety and feasibility, and patients will be followed for 30 days after resection of their primary tumors to assess these outcomes. This includes safety evaluations on treatment period Day 1 (diagnostic laparoscopy), Day 2 (±1 day, HA chemotherapy), Day 4 (+2 business days), Day 14 (±5 business days, day of primary tumor resection), every day throughout the perioperative hospitalization, and at outpatient follow-up (30 days ±10 business days after surgery for resection of the primary tumor).

Following the short-term follow-up period, patients move to long-term follow-up, which will occur every three months (±20 business days) after resection of the primary tumor, for a period of up to three years. Long-term secondary endpoints include DFS, LMFS, and OS.

As mentioned, a biobanking effort is built into this study to support prespecified correlative scientific objectives. This includes acquisition of peripheral blood and liver biopsies at the time of diagnostic laparoscopy (Day 1), acquisition of peripheral blood, liver biopsies, the primary tumor, and regional lymph nodes at the time of resection of the primary tumor (Day 14 ±5 days), and acquisition of peripheral blood at outpatient follow-up appointments. Correlative studies include multisite immune profiling, assessment of the HOMB both before and after HA chemotherapy, and dynamic assessment of ctDNA.

We will include both patients planned to undergo surgery before chemotherapy, as well as patients planned to receive systemic chemotherapy before surgery. This will allow us to test the safety and feasibility of adding single-dose neoadjuvant HA chemotherapy prior to surgery across the real-world treatment strategies employed in typical clinical practice. All patients receive HA chemotherapy in addition to standard-of-care surgery and systemic chemotherapy, so as not to withhold the treatment approach currently associated with best outcomes.

Hepatic Artery Chemotherapy for Patients With Localized Pancreas Cancer

A Window-of-Opportunity Trial Using Neoadjuvant Hepatic Artery Chemotherapy for Patients With Localized Pancreas Cancer

Upon completion of the project, we wish to make our cohort available as well as the coding and instructions for our analysis for replication purposes. The Duke Research Data Repository (RDR) will be used for this purpose. The Duke RDR is an openly accessible preservation archive maintained by the Duke University Libraries. The data will be preserved in the RDR for the long-term according to RDR policies and procedures. The RDR provides for automated backup of all data, which provides an added layer of protection and security for the data.

Number of enrolled patients that receive HA chemotherapy followed by planned standard-of-care surgical resection

Number of months without disease progression.

Number of months without metastasis to the liver.

Duke University

Micronutrients

Leucovorin

Fluorouracil

Patients with potentially resectable colorectal liver metastases will undergo hepatic artery infusion pump placement. Subsequent hepatic artery infusion of floxuridine via the HAIP as well as standard of care Dutch systemic chemotherapy (FOLFOX or FOLRIRI) will be administered in a combined chemotherapy schedule.

Administration of intra-arterial floxuridine via the HAIP (HAIP chemotherapy) to the liver with concomitant Dutch standard of care systemic FOLFOX (5-FU, leucovorin and oxaliplatin) or FOLFIRI (5-FU, leucovorin and irinotecan).

Surgical implantation of hepatic artery infusion pump (HAIP) followed by administration of the combined chemotherapy (HAIP and systemic).

Tricumed IP2000V infusion pump

Myrtle F Krul, MD

Roos Steenhuis, MSc

Koert FD Kuhlmann, MD, PhD

The PUMP-IT study is designed to prove the feasibility of HAIP chemotherapy with concomitant standard systemic chemotherapy (FOLFOX and FOLFIRI) in the Netherlands. This study will include patients with both unresectable CRLM and resectable CRLM with an indication for upfront systemic therapy (further referred to as potentially resectable CRLM), without extrahepatic metastases. The study will be performed in two tertiary referral centers in the Netherlands.

RATIONALE - Colorectal cancer (CRC) is the third most common cancer with an annual incidence of 14.000 patients in the Netherlands. Of all patients with metastases, 32% have isolated colorectal liver metastases (CRLM). Local treatment of CRLM, i.e. resection, ablation and/or stereotactic radiotherapy, is the only potentially curative option. Unfortunately over 75% of these patients have CRLM which are (initially) not suitable for such local treatment.

Current treatment of unresectable CRLM includes subsequent lines of systemic (chemo)therapy aiming to convert the CRLM from an unresectable to a resectable or local treatable state in order to prolong survival. Conversion rates of modern first line systemic chemotherapeutic regimens, as described in multiple retrospective studies with highly selected patients, are observed in 10-76% of patients, resulting in a 5-year survival of 33-43% after conversion. Patients with progressive disease on first line therapy are offered second line systemic therapy. Conversion during second line systemic therapy is rare and described in only 7-13.5% of patients. These patients have a poor prognosis with a median OS of approximately 10-15 months. However, overall survival (OS) of patients undergoing local treatment after conversion on second line systemic therapy is comparable to what is observed after conversion on first line systemic therapy.

Hepatic arterial infusion pump (HAIP) can deliver high-dose regional chemotherapy to the CRLM using their unique arterial blood supply. Floxuridine is used for HAIP chemotherapy because of the advantages of having a half-life of ten minutes, a 95% first-pass effect and allowing high intrahepatic dosing resulting in increased hepatic exposure by a factor 400, with minimal systemic exposure (e.g. complications). These specific properties of HAIP chemotherapy make it possible to combine high-dose local HAIP therapy with standard of care systemic therapy.

Several single center studies from Memorial Sloan Kettering Cancer Center (MSKCC) (New York, USA) have shown high response rates with HAIP chemotherapy in combination with systemic therapy for unresectable CRLM. Conversion to resection of the initially unresectable CRLM have been observed in up to 57% of chemo-naïve patients and in 20%-38% of patients with prior systemic therapy treated with the combination of HAIP and systemic therapy. Irrespective of conversion, the combined therapy resulted in a median OS of 50.8-76.6 months and a 5-year OS of 51.9% for chemo-naïve patients. The median and 5-year OS was 27.7-35 months and 27.9%, respectively, for patients who have been treated with systemic therapy before.

Although these results are impressive, they come from a single center and have not yet been confirmed elsewhere. Most important reasons were the technically challenging surgical procedure of HAIP implantation and the need for stringent monitoring and specific management of HAIP chemotherapy requiring a highly skilled multidisciplinary treatment team.

A study investigating combined treatment is required to prove feasibility in a multicenter setting outside MSKCC before a multicenter randomized phase III trial can be initiated in the Netherlands.

STUDY DESIGN - All eligible patients who signed informed consent (registration) and meet all inclusion criteria (inclusion) will undergo surgical HAIP implantation. HAIP function is evaluated with a perfusion test during surgery and postoperatively before starting drug treatment. Start of combined HAIP chemotherapy and systemic chemotherapy is aimed within 6 weeks postoperatively. Clinical and laboratory evaluations and chemotherapy administration are scheduled every two weeks. Response evaluations will be conducted with CT thorax/abdomen and CEA measurement every 2 HAIP cycles (every 4 systemic chemotherapy cycles) during combined therapy.

The combined therapy cycles are continued until disease progression, severe toxicity, CRLM conversion to surgical local treatment or patients withdrawal. After HAIP chemotherapy discontinuation, treatment and/or follow-up are according to standard clinical practice.

Patients with potentially resectable (i.e. unresectable or upfront resectable with an indication for upfront systemic therapy) will receive hepatic artery infusion pump chemotherapy, consisting of floxuridine (FUDR), combined with standard of care systemic therapy (FOLFOX or FOLFIRI).

Hepatic Arterial Infusion Pump Chemotherapy Combined With Systemic Chemotherapy (PUMP-IT)

Hepatic Arterial Infusion PUMP Chemotherapy Combined With systemIc chemoTherapy for Potentially Resectable Colorectal Liver Metastases: The PUMP-IT Study.

The quality of life will be examined with validated questionnaires (EORTC QLQ-C30 \& EQ-5D-3L).

The percentage of patients that complete two cycles of combined chemotherapy (HAIP chemotherapy and systemic therapy) after being scheduled for surgical implantation.

Surgical complications will be defined according to Clavien-Dindo surgical complications score. Complications of Clavien-Dindo grade 3 or higher are recorded for the first 90 days after surgery. Postoperative complications include those related to the HAIP implantation. Postoperative mortality is defined as any death during hospitalization or within 90 days from surgery.

Toxicity grade 3 or higher will be recorded from the time of study inclusion according to the CTCAE criteria.

Treatment related serious adverse events (SAE) and adverse events (AE) of grade 3 or higher will be collected continuously from the time of study inclusion until the end of combined chemotherapy. AE are followed up until the event is either resolved or adequately explained, even after the patient has completed his/her study treatment. Nature and duration of any hospitalization, treatment of any AE, and nature and duration of any outpatient care will be recorded.

Response rates of CRLM will be measured according to RECIST criteria

PFS will be defined from inclusion date until disease progression.

OS will be defined from inclusion date until death.

Conversion rate is defined as the percentage of patients in whom CRLM convert from an unresectable to a resectable state and undergo surgical treatment with curative intent. Possibility of local treatment is at the discretion of the multidisciplinary liver panel.

Erasmus Medical Center

The Netherlands Cancer Institute

Liver Neoplasms

Liver Diseases

\[0.16\* mg/kg/day X 30 ml\] / pump flow rate

\* If the patient is \>25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles.

FLOXURIDINE

William Jarnagin, MD

This phase II study aims to evaluate regional chemotherapy in patients with unresectable primary hepatic malignancy. Specifically, eligible patients with hepatocellular carcinoma and peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary Surgery service, will undergo hepatic artery pump placement and continuous infusion of FUDR. The protocol includes radiological and biological correlative studies.

This phase II study aims to evaluate regional chemotherapy in patients with unresectable primary hepatic malignancy. Specifically, eligible patients with hepatocellular carcinoma and peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary Surgery service, will undergo hepatic artery pump placement and continuous infusion of FUDR. The protocol includes radiological and biological correlative studies.

The primary objectives of the study are 1.) to assess the efficacy of continuous hepatic arterial infusion (HAI) of FUDR and dexamethasone (DEX) in patients with unresectable hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC) and 2.)to assess patient tolerability of this therapy stratified by degree of underlying hepatic parenchymal disease, as determined on liver biopsy. Secondary objectives are 1.) to use dynamic MRI to evaluate changes in tumor perfusion during treatment and to correlate these findings with radiographic tumor response and 2.) to investigate molecular genetic changes associated with these tumors using comparative genomic hybridization and cDNA array from tumor and liver biopsy specimens obtained at the time of operation. All patients enrolled in the study will begin HAI FUDR at 0.16 mg/kg/day. An initial cohort of 12 patients will be enrolled and treated. Dose limiting toxicity (DLT) related to FUDR is defined by changes in liver function blood tests that are unrelated to disease progression or mechanical biliary obstruction. Modifications in the FUDR dose may be required. A patient will be considered intolerant of therapy if treatment must be stopped due to DLT at least once during the first 3 months. Treatment will continue as long as there is at least stable disease and acceptable toxicity.

If, in the initial cohort, 4 or more patients (\> 30%) are intolerant of therapy or if there are not at least 2 responders, then the study will be terminated. Otherwise, accrual will continue to a maximum of 35 patients.

A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy

To assess the efficacy of continuous arterial infusion (HAI) of FUDR (Floxuridine) and dexamethasone (DEX) in patients with unresectable hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC).

Toxicity evaluated and graded according to the National Cancer Institute, CTCAE v4.0

Median Survival from Initiation of Hepatic Arterial Infusion

Wake Forest University

Memorial Sloan Kettering Cancer Center

FLOXURIDINE: \[0.16\* mg/kg/day X 30 ml\] / pump flow rate

\* If the patient is \>25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles.

Floxuridine + Dexamethasone

Age, Continuous

Dr. William Jarnagin, MD

Patients with hepatocellular carcinoma and peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary Surgery service will undergo hepatic artery pump placement and continuous infusion of Floxuridine.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Codman Catheter/Synchromed Pump Hepatic Artery Chemotherapy for Unresectable Colorectal Metastases/Intrahepatic Cholangiocarcinoma	NCT04276090	Bile Duct Neopl... Colorectal Neop...	Hepatic artery ... Hepatic artery ... Systemic chemot... Systemic chemot...	18 Years -	University of Kentucky
Hepatic Artery Chemotherapy for Patients With Localized Pancreas Cancer	NCT05634720	Pancreatic Duct...	HA Chemotherapy	18 Years -	Duke University
Hepatic Arterial Infusion Pump Chemotherapy Combined With Systemic Chemotherapy (PUMP-IT)	NCT04552093	Colorectal Neop...	Floxuridine Tricumed IP2000...	18 Years - 115 Years	The Netherlands Cancer Institute
A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy	NCT00587067	Hepatic Cancer	FLOXURIDINE	18 Years -	Memorial Sloan Kettering Cancer Center
Codman Catheter/Synchromed Pump Hepatic Artery Chemotherapy for Unresectable Colorectal Metastases/Intrahepatic Cholangiocarcinoma	NCT04276090	Bile Duct Neopl... Colorectal Neop...	Hepatic artery ... Hepatic artery ... Systemic chemot... Systemic chemot...	18 Years -	University of Kentucky
A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy	NCT00587067	Hepatic Cancer	FLOXURIDINE	18 Years -	Memorial Sloan Kettering Cancer Center
A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy	NCT00587067	Hepatic Cancer	FLOXURIDINE	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for fudr

Every month we try and update this database with for fudr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fudr

Every month we try and update this database with for fudr cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fudr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.