Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Ductal

Constriction, Pathologic

Bile Duct Diseases

Choledocholithiasis

Common Bile Duct Diseases

Biliary Tract Diseases

Gastrointestinal Diseases

Gallstones

Cholelithiasis

Cholecystolithiasis

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

All patients will undergo endoscopic retrograde cholangiopancreatography (ERCP) that is indicated for suspected or confirmed choledocholithiasis or biliary strictures. "Air" contrast cholangiography using carbon dioxide gas will be performed with standard fluoroscopy and digital subtraction fluoroscopic image capture followed by routine cholangiography using iodinated contrast and standard fluoroscopy. Carbon dioxide (CO2) is routinely used in ERCP procedures and would flow into the biliary tree of patients at the time of ERCP, irrespective of this study's interventions. Digital subtraction image capture is a commercially available setting on certain fluoroscopy units that optimizes resolution with air or CO2 used as a contrast medium.

Carbon dioxide (CO2) will be injected into the biliary tree (which is already exposed to CO2 during routine ERCP) and images will be obtained by using fluoroscopy and digital subtraction imaging (a specific setting on certain fluoroscopy tables).

"Air" contrast cholangiography using carbon dioxide gas

Andrew Y. Wang, MD

Carbon dioxide (CO2) gas is widely used for luminal insufflation during endoscopic retrograde cholangiopancreatography (ERCP) of the biliary tract. While frequently observed during routine ERCP, there are few data on the topic of "air" or "CO2" cholangiography. Our primary aim is to compare radiographic cholangiograms in patients with biliary tract disease (from stones or strictures) during ERCP obtained by using carbon dioxide as the contrast medium vs. conventional iodinated contrast.

It has been recommended that endoscopic retrograde cholangiopancreatography (ERCP) be performed using carbon dioxide (CO2) instead of room air as the infused "air" or gas for luminal insufflation for reasons of improved patient comfort and in case of procedural adverse events (as CO2 is more quickly absorbed by the body and as it can be exhaled via the lungs). Air cholangiograms are often incidentally visible on fluoroscopy (radiographically) during ERCP prior to injection of iodinated contrast into the biliary tree. Despite the information from an air cholangiogram being readily available in many instances, biliary endoscopists and radiologists who read the fluoroscopic images taken during ERCP do not usually comment or interpret the "air" or "CO2" cholangiograms. Consequently, very little data is available on the topic of "air" or "CO2" cholangiography. As a contrast medium for cholangiography, CO2 might be safer than iodinated contrast, which is the standard contrast medium used during ERCP, as iodinated contrast cannot be easily absorbed by the body and as it can be trapped proximal to obstructing biliary stones or strictures and lead to biliary tract infection.

This is a prospective cohort study that will enroll patients undergoing ERCP for suspected choledocholithiasis and/or biliary stricture(s). If they did not participate in this study, these patients would still require an ERCP with CO2 used as the endoscopically insufflated "air" medium. Enrolled patients will undergo an initial cholangiogram with CO2 (injected into the bile ducts) utilizing both conventional fluoroscopy and digital subtraction fluoroscopic imaging, followed by conventional cholangiography using iodinated contrast (injected into the bile ducts). Digital subtraction fluoroscopic imaging is a commercially available setting on certain fluoroscopy units that optimizes resolution with air or CO2 used as a contrast medium. Findings on CO2 cholangiography will be compared to those obtained from pre-procedural abdominal imaging along with the cholangiogram done using iodinated contrast at the time of the ERCP procedures.

Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP

CO2 Cholangiography as an Alternative to Iodinated Contrast in Endoscopic Retrograde Cholangiopancreatography

For choledocholithiasis: correct identification of the number and location of stones. For biliary strictures: correct identification of number and location of strictures.

Fluoroscopy/radiation usage/exposure will be measured for each imaging modality and then compared

University of Virginia

Associate Professor of Medicine

Esophageal Neoplasms

Carcinoma, Hepatocellular

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Dose Escalation Phase: Ascending doses of CGX1321 will be administered by cohort to determine the maximum tolerated dose. Patients will receive CGX1321, once daily, orally, for 3 weeks (21 days) followed by a one week (7 day) washout period in each 28 day cycle, according to the cohort they are assigned.

Dose Expansion Phase: Patients will receive the recommended dose (identified in the Dose Expansion Phase) of CGX1321

CGX1321

Peter Ding

Lin Shen, MD

Jifang Gong

Aiping Zhou, MD

Wen Zhang, MD

This is a multi-center, open label, repeat dose, Phase 1 study consisting of a Dose Escalation Phase and a Dose Expansion Phase to evaluate safety, pharmacokinetics, and clinical activity.

The purpose of the Dose Escalation Phase is to examine the safety and determine the maximum tolerated dose of CGX1321 when administered to subjects with advanced GI tumors that have relapsed or are refractory to or not considered medically suitable to receive standard of care treatment.

Once the dose is identified in the Dose Escalation Phase, the Dose Expansion Phase will start. The purpose of the Dose Expansion Phase is to continue to examine the safety and confirm the final Phase 2 dose of CGX1321 when administered to subjects with advanced GI tumors who meet the entry criteria.

Phase 1 Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors

A Phase 1 Open-label Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors

Guangzhou Curegenix Co. Ltd.

Curegenix Inc.

Gland and Hormone Related Diseases

Recurrence

Pancreatic Neoplasms

Disease Attributes

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Capecitabine

Afatinib

Tyrosine Kinase Inhibitors

Antimetabolites

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Patients receive afatinib dimaleate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate

Laboratory Biomarker Analysis

Elena G. Chiorean

This phase I/Ib trial studies the side effects and best dose of afatinib dimaleate when given together with capecitabine in treating patients with solid tumors, pancreatic cancer, or biliary cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment and has not responded to previous treatment. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving afatinib dimaleate together with capecitabine may be a better treatment for solid tumors, pancreatic cancer, or biliary cancer.

PRIMARY OBJECTIVES:

I. Evaluate the safety, maximum tolerated dose (MTD), and the recommended phase II dose (RP2D) of afatinib dimaleate (afatinib) in combination with capecitabine in patients with advanced solid tumors (phase I) and pancreatico-biliary cancers (phase Ib). (Phase I/Ib)

SECONDARY OBJECTIVES:

I. Evaluate biomarkers of response from tumor biopsies, including markers related to the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) pathways via OncoPlex or other equivalent gene sequencing assay. (Phase I/Ib)

II. Evaluate rates of response and stable disease, duration of response, time to progression, progression-free and overall survival. (Phase I/Ib)

OUTLINE: This is a phase I, dose-escalation study of afatinib dimaleate followed by a phase Ib study.

Patients receive afatinib dimaleate orally (PO) once daily (QD) on days 1-21 and capecitabine PO twice daily (BID) on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 3 years.

Afatinib Dimaleate and Capecitabine in Treating Patients With Advanced Refractory Solid Tumors, Pancreatic Cancer or Biliary Cancer

Phase I/IB Multi-center Study of Irreversible EGFR/HER2 Tyrosine Kinase Inhibitor Afatinib (BIBW 2992) in Combination With Capecitabine for Advanced Solid Tumors and Pancretico-Biliary Cancers

Adverse events will be tabulated and summarized by dose levels. Summary tabulations will be presented displaying the number of observations, mean, standard deviation, median, minimum, and maximum for continuous variables, and the number and percentage per category for categorical data. Toxicity measurement will be accompanied by 90% confidence intervals.

DLTs will be tabulated and summarized by dose levels. Summary tabulations will be presented displaying the number of observations, mean, standard deviation, median, minimum, and maximum for continuous variables, and the number and percentage per category for categorical data. Toxicity measurement will be accompanied by 90% confidence intervals.

Defined as the dose at which 0/3 or =\< 1/6 patients experience a DLT graded according to NCI CTCAE version 4.0, will be assessed.

Defined as the best tolerated dose overall, considering overall toxicity, including beyond course 1, will be evaluated.

Will be summarized using mean +/- standard deviation. Baseline biomarker profile will also be summarized by the categories of treatment responses. Logistic models with objective response and stable disease as outcome and the baseline tumor profile as covariate will be fitted to evaluate their association. Correlative analysis of the presence of specific biomarkers and objective response/stable disease and progression free survival (PFS) (for patients in expansion cohorts) will be performed using Chi-square test or Fisher?s exact tests, as appropriate.

Duration of response will be assessed with the Kaplan-Meier method.

Duration of stable disease will be assessed with the Kaplan-Meier method.

Overall survival will be assessed with the Kaplan-Meier method.

Response rates will be tabulated and summarized by dose levels. Response rate measurement will be accompanied by 90% confidence intervals.

Stable disease will be tabulated and summarized by dose levels.

Time to progression will be assessed with the Kaplan-Meier method.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP	NCT02611453	Choledocholithi... Bile Duct Disea... Bile Duct Carci...	"Air" contrast ...	18 Years -	University of Virginia
Phase 1 Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors	NCT03507998	Colorectal Aden... Gastric Adenoca... Pancreatic Aden... Bile Duct Carci... Hepatocellular ... Esophageal Carc... Gastrointestina...	CGX1321	18 Years -	Curegenix Inc.
Afatinib Dimaleate and Capecitabine in Treating Patients With Advanced Refractory Solid Tumors, Pancreatic Cancer or Biliary Cancer	NCT02451553	Advanced Malign... Bile Duct Carci... Recurrent Malig... Recurrent Pancr... Stage III Pancr... Stage IVA Pancr... Stage IVB Pancr...	Afatinib Dimale... Capecitabine Laboratory Biom...	19 Years -	University of Washington
Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP	NCT02611453	Choledocholithi... Bile Duct Disea... Bile Duct Carci...	"Air" contrast ...	18 Years -	University of Virginia

Spots Global Cancer Trial Database for bile duct carcinoma