Neoplasms

All Conditions

Rare Diseases

Carcinoma

Cholangiocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Hematinics

Gemcitabine

Dexamethasone

Dexamethasone acetate

Liver Extracts

Floxuridine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antimetabolites

This is an open-label single arm study. multi-institution phase I dose escalating trial of adjuvant HAIP FUDR and Gemcitabine chemotherapy after curative resection of ICC. Hepatectomy with or without bile duct reconstruction and pump placement are performed. The patients will start therapy 4 weeks postoperatively. They will receive HAI FUDR/Dex and systemic gemcitabine in the following dose escalation levels of gemcitabine. The dose of HAI FUDR will be fixed. A classic 3+3 cohort dose escalation scheme will be used to identify the MTD of the combination.

Level 1: Systemic gemcitabine 650mg/m\^2 Day 1 and 15 and HAI FUDR/Dex 0.12mg/kg/day Day 1-14 Level 2.Systemic gemcitabine 800mg/m\^2 Day 1 and 15 HAI FUDR/Dex 0.12 mg/kg/day Day 1-14 Level 3. Systemic gemcitabine 1000mg/m\^2 Day 1 and 15 HAI FUDR/Dex 0.12 mg/kg/day Day 1-14

Liver resection and placement of hepatic artery infusion pump

FLOXURIDINE

DEXAMETHASONE

GEMCITABINE

Andrea Cercek, MD

This is a Phase I study, which means we want to find out what effects, good and/or bad, this combination of drugs may have on the patient and the liver cancer at different dose levels. All patients will have an operation to remove tumors in the liver and may have a pump placed in their abdomen.

On this study, both drugs given have been used in other patients for treatment of cholangiocarcinoma and other gastrointestinal cancers. Both drugs are approved by the food and drug administration (FDA) for treatment of liver cancer, but the two drugs have only been combined in a few patients.

That means that in this trial we also want to find out if this combination is safe.

The study will also evaluate if this treatment works in delaying or stopping the cancer from coming back after surgery.

Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma

Phase I Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma

All toxicities will be rated as per the NCI Common Toxicity Criteria (CTC AE version 4.0) except neurosensory and hepatic enzyme toxicities related to intrahepatic pump therapy.

we will evaluate the recurrence-free survival of patients in this trial using Kaplan-Meier methods.

Ohio State University

University of Texas Southwestern Medical Center

Washington University School of Medicine

Memorial Sloan Kettering Cancer Center

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

Cornelius A Thiels

Cornelius Thiels, DO, MBA

The purpose of this study is to evaluate the surgical outcomes and the quality of life (QOL) in patients undergoing hepatic artery infusion pump placement for colorectal liver metastases (CRLM).

Patient Outcomes After Hepatic Artery Infusion Pump Placement

Patient Reported Outcomes After Hepatic Artery Infusion Pump Placement

Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.

Number of days following hepatic artery infusion pump placement until chemotherapy is started

Complications with hepatic artery infusion pump placement

Complications with hepatic artery infusion chemotherapy

Mayo Clinic

Principal Investigator

Head and Neck Neoplasms

Upon tube feeding initiation determined by the HNC multidisciplinary team, the patients will be randomized into three different groups, each consisting of 20 patients each: Bolus (Group 1), Gravity (Group 2), and Pump (Group 3). The randomization process within these three groups will based on 1) age and 2) estimated caloric need. For example, if we have three 60-year-old patients whose estimated kcals needs are ≤ 1900kcals/day, then each patient will be randomized to either Bolus, Gravity or Pump group. Another example is that if we have two 45-year-old patients whose estimated needs are 2400kcals/day, then one patient will randomly be assigned to the Bolus group, and the other one will be randomly assigned to the Gravity group. The third patient that will fit that category will be assigned to the Pump group.

The patients will be randomized into 3 different groups: Bolus, Gravity, and Pump. The randomization process will be based on age and estimated caloric needs (i.e if we have three 60-year-old patients whose estimated kcals needs are ≤ 1900kcals/day, then each patient will be randomized to either of the groups).

Each patient from each group will be receiving tube feeding education to their by RD. For consistency reasons, the same type of tube feeding formula (1.5 kcal/ml, no fiber) will be used. Patients' weight, tube feeding tolerance, and amount of estimated calories and protein met will be monitored weekly.

Bolus

Gravity

Pump

Andreea Nguyen, MS in Nutrition

The purpose of this study is to assess the optimal tube feeding method (bolus, gravity or pump) by analyzing percent weight loss, tolerance of enteral feeds, and percent of estimated calorie and protein needs in 60 patients with squamous cell carcinoma of the head and neck undergoing chemoradiation therapy.

It is a great challenge to maintain the nutritional status of the head and neck cancer (HNC) patients through treatment advances such as combined chemoradiation therapy or CRT. For all these reasons, HNC patients undergoing treatment, frequently require alternate methods of nutrition support such as as enteral tube feeding via a gastrostomy tube.Upon gastric tube feeding initiation, the registered dietitian (RD) must consider the three different methods: bolus (using a syringe), gravity (using gravity feeding bags), and pump (using a tube feeding pump).

Typically, patients are started on bolus (OPTION A), changed to gravity (OPTION B) if bolus feeds are not tolerated, and ultimately changed to pump (OPTION C) if gravity feeds are not tolerated. The concern is that in this process of starting with OPTION A, and moving to OPTION B or further to OPTION C, the patient may experience unintentional weight loss and dehydration related to tube feeding intolerance and/or tube feeding inadequacy. Consequently, this places the patient at risk of, but not limited to, hospital admission for dehydration and/or malnutrition, and treatment interruption. Therefore, exploring the idea of an optimal feeding method and starting patients on it from the beginning, may improve patient outcomes in terms of nutritional status.

Optimal Tube Feeding Method in Head and Neck Cancer Patients

The Optimal Tube Feeding Method in Head and Neck Cancer Patients: A Comparison Between Bolus, Gravity, and Tube Feeding Pump.

Baylor Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma	NCT01938729	Intrahepatic Ch... Peripheral Chol... Cholangiolar Ca... Cholangiocellul...	Liver resection... FLOXURIDINE DEXAMETHASONE GEMCITABINE	18 Years -	Memorial Sloan Kettering Cancer Center
Patient Outcomes After Hepatic Artery Infusion Pump Placement	NCT05468593	Colorectal Live... Colorectal Canc...		18 Years -	Mayo Clinic
Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma	NCT01938729	Intrahepatic Ch... Peripheral Chol... Cholangiolar Ca... Cholangiocellul...	Liver resection... FLOXURIDINE DEXAMETHASONE GEMCITABINE	18 Years -	Memorial Sloan Kettering Cancer Center
Optimal Tube Feeding Method in Head and Neck Cancer Patients	NCT01536782	Head and Neck C...	Bolus Gravity Pump	18 Years -	Baylor Research Institute

Spots Global Cancer Trial Database for pump

Every month we try and update this database with for pump 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 pump

Every month we try and update this database with for pump 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 pump 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.