Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Sarcoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Diseases

Soft Tissue Sarcoma

Small Intestinal Adenocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Capecitabine

Panitumumab

Antineoplastic Agents, Immunological

Starting Dose of Panitumumab: 9 mg/kg by vein over 60 minutes on day 1 of a 14 day cycle.

Starting Dose Level: 9 mg/kg by vein over 60 minutes on day 1 of a 14 day cycle.

Michael Overman, MD

The goal of this clinical research study is to learn if panitumumab can help to control advanced cancer of the small bowel or ampulla of Vater. The safety of this drug will also be studied.

Panitumumab is designed to "turn off" a protein that is important in cell growth. This may stop the growth of cancer cells.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive the study drug during 14 day study "cycles."

On Day 1 of every cycle, you will receive panitumumab by vein over about 60-90 minutes.

Study Visits:

On or before Day 1 of each cycle:

* You will have a physical exam, including measurement of your weight.
* Your performance status will be recorded.
* You will be asked about any symptoms you may be experiencing and any drugs you may be taking.
* Blood (about 2 tablespoons) will be drawn for routine tests.

Every 4 cycles:

* You will have a chest X-ray or a computed tomography (CT) scan of your chest to check the status of the disease.
* You will have a CT or MRI scan to check the status of the disease. If your scan shows that you are responding to the treatment, you will have another CT or MRI scan 6 weeks later.

Length of Study:

You may continue receiving the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur.

End-of-Treatment:

After you stop taking the study drugs for any reason, you will have an end-of-treatment visit. The following tests and procedures will be performed:

* You will have a physical exam, including measurement of your weight.
* Your performance status will be recorded.
* You will be asked about any symptoms you may be experiencing and any drugs you may be taking.
* Blood (about 2 tablespoons) will be drawn for routine tests.
* If the doctor thinks it is needed, you will have a CT or MRI scan of the abdomen and pelvis to check the status of the disease.

Follow-Up:

Thirty (30) days after your last dose of study drug(s), you will be asked about any symptoms you may be experiencing and any drugs you may be taking. If you are unable to come to MD Anderson for this, the study staff will call you and ask you these questions. This call will last about 30 minutes.

You will then be called every 3 months and asked the same questions. Each call will last about 15-30 minutes.

If you are taken off study treatment for reasons other than the disease getting worse, you will have a CT or MRI scan of the abdomen and pelvis to check the status of the disease every 12 weeks (+/- 2 weeks) after the End-of-Treatment visit. This will be done until the disease gets worse and if you do not start any other anti-cancer treatment.

This is an investigational study. Panitumumab is commercially available and FDA approved to treat a certain type of colorectal cancer. Its use in this type of cancer is investigational.

Up to 27 patients will take part in this study. All will be enrolled at MD Anderson.

CAPOX in KRAS Wild-Type Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater

Phase II Study of Panitumumab in KRAS Wild-type Locally Advanced or Metastatic Adenocarcinoma of the Small Bowel or Ampulla of Vater

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Time interval in months from date of first treatment until the date of first documented progression of participants.

Amgen

M.D. Anderson Cancer Center

Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.

Capecitabine + Panitumumab + Oxaliplatin

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Michael J Overman/ Professor, GI Medical Oncology

Response Rate (RR)

Overall Progression-free Survival (PFS) for CAPOX and Panitumumab

Overall Study

Gland and Hormone Related Diseases

Symptoms and General Pathology

Cholangiocarcinoma

Pancreatic Neoplasms

Disease Progression

Pancreatic Cancer

Bile Duct Cancer

Biliary Tract Cancer

Bone Density Conservation Agents

Pembrolizumab

Denosumab

Immune Checkpoint Inhibitors

Patients (Karnofsky performance status ≥70) will be recruited and dosed with RXC004 (2 mg once daily \[QD\], orally) within 6 weeks of progression following 1st line SoC treatment.

Patients (Eastern Cooperative Oncology Group \[ECOG\] performance status 0-1) will be recruited and dosed with RXC004 within 6 weeks of progression, following 1st line SoC treatment.

Patients (ECOG performance status 0-1) will be recruited and dosed with RXC004 (1.5 mg QD, orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression, following 1st line Soc treatment.

RXC004 will be administered orally, 2 mg QD; Dose Formulation: 0.5 mg or 1 mg capsules.

RXC004

RXC004 will be administered orally, 2 mg QD (Cohort 1, Module 2) and 1 mg QD (Cohort 2, Module 2); Dose Formulation: 0.5 mg or 1 mg capsules.

RXC004 will be administered orally, 1.5 mg QD; Dose Formulation: 0.5 mg or 1 mg capsules.

Denosumab will be administered via subcutaneous (SC) injection, 120 mg once every month; Use: Prophylactic

Pembrolizumab will be administered via intravenous infusion, 400 mg dose once every 6 weeks

pembrolizumab

This study is to evaluate the preliminary efficacy and safety of RXC004 monotherapy and in combination with pembrolizumab in advanced solid tumours that have progressed following SoC treatment.

This Phase II, modular, open label, multicentre study initially opened with ring finger protein 43 (RNF43) loss of function (LoF) mutation-positive pancreatic ductal adenocarcinoma (PDAC) (Module 1) and molecularly unselected biliary tract cancer (BTC) (Module 2) modules. Module 3 will investigate RXC004 in combination with pembrolizumab in BTC. Modules 1 and 2 are monotherapies and Module 3 is the combination therapy.

The primary objective of the study is to assess the preliminary efficacy of RXC004 in each module. This will be evaluated in terms of progression free survival (PFS) at 6 months in Modules 1 and 2, and in terms of Objective response rate (ORR) in Module 3. Following radiological progression, patients will be followed-up for survival.

A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2)

A Modular, Phase II, Open-Label, Multicentre Study to Assess the Preliminary Efficacy and Safety of RXC004, in Patients With Advanced Solid Tumours That Have Progressed Following Therapy With Current Standard of Care

To assess the anti-tumour activity of RXC004. Progression free survival rate at 6 months is defined as the proportion of patients who remain alive and free of progression at 6 months.

To assess the anti-tumour activity of RXC004 as combination therapy. ORR, defined as the proportion of patients with a best overall response of complete response or partial response, based on local investigator assessment, as defined in RECIST 1.1.

To further assess the preliminary efficacy of RXC004. ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR), based on local Investigator assessment, as defined in RECIST 1.1.

To further assess the preliminary efficacy of RXC004 as monotherapy and as combination therapy. DCR is defined as the proportion of patients with a best overall response of either CR, PR or stable disease (SD) for at least 6 weeks.

To further assess the preliminary efficacy of RXC004 as monotherapy and as combination therapy. PFS is defined as the time from first dose of study treatment until the date of disease progression or death (by any cause in the absence of progression), regardless whether the patient withdraws from the assigned study treatment or receives another anticancer prior to progression.

To further assess the preliminary efficacy of RXC004 as monotherapy and as combination therapy. Percentage change in tumour size will be derived at each visit by the percentage change from baseline in the sum of diameters of target lesions. The best percentage change in tumour size will be the patients value representing the largest decrease (or smallest increase) from baseline in tumour size.

To further assess the preliminary efficacy of RXC004 as monotherapy and as combination therapy. OS is defined as the time from first day of study treatment until death due to any cause.

To assess the pharmacokinetic (PK) of RXC004 as monotherapy and as combination therapy.

To assess the PK of RXC004 as monotherapy and as combination therapy.

To assess the safety and tolerability profile of RXC004 as monotherapy and as combination therapy.

Merck Sharp & Dohme LLC

Redx Pharma Plc

Biliary Tract Neoplasms

Biliary Tract Diseases

Patients undergoing cholecystectomy for gall stones

Jill E. Koshiol, M.D.

The key aims of this study include estimation of possible risk associated with a history of gallstones, bacterial infection for the biliary tract, other medical history, diet, use of tobacco and alcohol, obesity, reproductive factors, and family history of cancer. Information will be used to examine risk patterns a) seperately by anatomic subsite; b) among patients with gallbladder cancer vs. controls undergoing cholecystectomy for gallstones; c) among the patients with bile duct cancer vs. Hospital controls without cancer who undergo surgery for removal of bile duct stones. We will also attempt to ascertain reasons for cancer who undergo surgery for removal of bile duct stones. We will also attempt to ascertain reasons for the rising incidence of biliary tract cancers in Shanghai. Serum collected from all subjects will be analyzed for estrogens and other hormones, vitamins C and E, cholesterol, and bacterial antibodies (including salmonella typhi, paratyphi, and escherischia coli). Bile fluid will be cultured for aerobic bacteria, and gallstones analyzed for color, cholesterol, and evidence of bacteria infection. A major challenge in biliary tract cancer research is to determine how cancer risk factors differ from those for gallstones or biliary duct stone disease, since many people have gallstones (or biliary duct stones) but few develop cancer....

The key aims of this study include estimation of possible risk associated with a history of gallstones, bacterial infection for the biliary tract, other medical history, diet, use of tobacco and alcohol, obesity, reproductive factors, and family history of cancer. Information will be used to examine risk patterns a) seperately by anatomic subsite; b) among patients with gallbladder cancer vs. controls undergoing cholecystectomy for gallstones; c) among the patients with bile duct cancer vs. Hospital controls without cancer who undergo surgery for removal of bile duct stones. We will also attempt to ascertain reasons for cancer who undergo surgery for removal of bile duct stones. We will also attempt to ascertain reasons for the rising incidence of biliary tract cancers in Shanghai. Serum collected from all subjects will be analyzed for estrogens and other hormones, vitamins C and E, cholesterol, and bacterial antibodies (including salmonella typhi, paratyphi, and escherischia coli). Bile fluid will be cultured for aerobic bacteria, and gallstones analyzed for color, cholesterol, and evidence of bacteria infection. A major challenge in biliary tract cancer research is to determine how cancer risk factors differ from those for gallstones or biliary duct stone disease, since many people have gallstones (or biliary duct stones) but few develop cancer.

A Population-Based Case-Control Study of Biliary Tract Cancers in Shanghai, China

National Cancer Institute (NCI)

Adenoma

forward-viewing endoscope with a Cap attached at the tip

Denise P Guimarães, MD, PhD

Leonardo C Silva, MD

The aim of this study is to compare the visualization rates of the ampulla of Vater using forward- viewing endoscopes with or without cap attached to the distal end in the same patient.

The complete visualization of the ampulla of Vater for the detection of ampullary neoplastic lesions is technically challenging with a forward-viewing endoscope. There are limited data in the relevant literature regarding the effectiveness of the Cap assisted forward viewing endoscope for accurate evaluation of the ampulla de Vater. Therefore, the aim of this study is to compare the visualization rates of the ampulla of Vater using forward-viewing endoscopes with or without cap attached to the distal end in the same patient.

The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater

Barretos Cancer Hospital

Principal Investigator

Vasoconstrictor Agents

Respiratory System Agents

Epinephrine

Racepinephrine

Epinephryl borate

Conventional snaring mucoal resection without submucosal injection

Conventional mucosal resction method following injeciton of diluted epinephrine mixture.

Conventional endoscopic mucosal resection of ampulla of Vater using a snare with electrocurrent.

Papillectomy without injection

Conventional endoscopic mucosal resection of ampulla of Vater without submucosal saline or diluted epinephrine injection.

Papillectomy with injection

Tae Hoon Lee, MD, PhD

Because the ampulla of Vater is strategically located at the confluence of the pancreatic and common bile ducts, endoscopic resection of papillary neoplasms may be technically different from endoscopic mucosal resection in other parts of the gastrointestinal tract. The best method of endoscopic ablation and the optimal period for surveillance have not been established.

While some endoscopists advocate the use of submucosal injection of either physiologic saline solution or dilute epinephrine, some do not. Whether physiologic saline solution or dilute epinephrine should be used is also not established. Submucosal injection of either dilute epinephrine or saline solution may be useful for avoiding inappropriate resection because failure to lift the tumor from the proper muscle layer of the duodenum may indicate deeper invasion18 and is the strongest predictor of malignancy.

In adenomas of the major duodenal papilla, however, some investigators do not recommend submucosal injection. Not only the surrounding mucosa at the region of the duodenal papilla but also the tumor is lifted by submucosal injection, so capturing the lesion with a snare becomes difficult.

Comparison on the Efficacy of Endoscopic Snare Papillectomy With or Without Submucosal Injection

A Prospective Comparative Study of Papillectomy

Following endoscopic papillectomy, complete resection will be estimated by pathologic examination

Immediate complications after papillecotmy Delayed complications during 24 hours

Soon Chun Hyang University

Small Intestine Cancer

Antimetabolites

Intravenous Oxaliplatin 130 mg/m\^2, Day 1 + Oral Capecitabine 750 mg/m\^2 twice daily Days 1-14.

Oral capecitabine 750 mg/m\^2 twice daily (total daily dose 1500 mg/m\^2) on Days 1-14 in 21 Day Cycle.

130 mg/m\^2 by vein Day 1 over 2 hours in 21 Day Cycle

Robert A. Wolff, MD

Primary Objective:

1. To determine the objective response rate (complete plus partial) to the combination of capecitabine (Xeloda) and oxaliplatin (Eloxatin) (XELOX) in patients with adenocarcinoma of the small bowel and ampulla of Vater.

Secondary objectives include determining the toxicity, time-to-treatment failure, and overall survival rates in patients treated with this combination.

Oxaliplatin is a chemotherapy drug designed to destroy cancer cells by interfering with DNA function, which is necessary for growth of new cells.

Capecitabine is a chemotherapy drug designed to destroy cancer cells by interfering with cell division, which is important to the growth of cancer.

You will receive 14 days of treatment followed by 7 days without treatment, 21 days in all, otherwise known as a "cycle" of therapy. On Day 1 of each cycle, you will receive oxaliplatin injected into a vein over a period of 2 hours. For this injection, you will need to have a small tube inserted into a vein under the skin of the chest (central venous line) to receive oxaliplatin. Oxaliplatin must be given at M.D. Anderson.

You will take capecitabine tablets twice a day for the first two weeks (Days 1-14) of each 3-week cycle. No treatment will be given for the next 7 days. You must take capecitabine within 30 minutes after breakfast and dinner, with morning and evening doses about 12 hours apart. You should take capecitabine by mouth with water, and not fruit juices. At the first treatment visit and every 3 weeks, you will receive enough capecitabine to last until the next visit. At each visit, you must return any capecitabine you have not used as well as all empty bottles.

During Cycle 1, routine blood tests (about 2 teaspoons of blood) will be done once a week. Before each new cycle of therapy, you will have a complete physical exam and blood (about 2 ½ teaspoons) will be collected for routine tests. You will be asked by the study doctor about all medications you have taken since starting the study drugs and any health problems that you may have experienced. Also, you will have an x-ray or computed tomography (CT) scan of the chest and either CT scans or magnetic resonance imaging (MRIs) of the tumor(s) every 3 cycles and at the end of the study. Additional tests may be done during the study if your doctor feels it is necessary for your care.

This study will require you to receive at least 3 cycles of treatment. However, if you experience severe side effects or your disease becomes worse, treatment may be delayed, stopped, or you may receive smaller doses of the treatment. You may continue to receive treatment on this study until the disease gets worse or you experience any intolerable side effects. If this happens, you will be taken off the study and your doctor will discuss other treatment options with you.

When you stop taking part in the study, you will have blood (about 3 teaspoons) collected for routine tests. You will have a physical exam and either a CT scan or an MRI to check on the status of the disease. You will be contacted by phone every three months for the rest of your life to check on your state of health and ask you about further symptoms you may be experiencing.

This is an investigational study. The drugs oxaliplatin and capecitabine are FDA approved for treatment of advanced cancer of the colon or rectum. The drugs are not approved for small bowel or ampulla of Vater cancer. Their use together in this study is investigational. Up to 30 people will take part in this study. All will be enrolled at M.D. Anderson.

Capecitabine and Oxaliplatin in Adenocarcinoma of the Small Bowel and Ampulla of Vater

A Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Adenocarcinoma of the Small Bowel and Ampulla of Vater

Overall response rate defined as Complete Response (CR), disappearance of all target lesions; or Partial Response (PR), at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\]. In addition to a baseline scan, confirmatory scans for those deemed to have achieved a PR or CR.

Sanofi-Synthelabo

Oxaliplatin + Capecitabine

Age Continuous

Robert Wolff, MD / Professor

Participants with CR

Participants with PR

Analysis was intent-to-treat; One patient developed an acute flare of Crohn's disease after one cycle of study treatment and was removed from study without undergoing restaging scans.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CAPOX in KRAS Wild-Type Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater	NCT01202409	Gastrointestina...	Panitumumab	18 Years -	M.D. Anderson Cancer Center
A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2)	NCT04907851	Advanced Solid ...	RXC004 RXC004 RXC004 Denosumab pembrolizumab	18 Years -	Redx Pharma Plc
A Population-Based Case-Control Study of Biliary Tract Cancers in Shanghai, China	NCT00339560	Biliary Tract C...		18 Years - 75 Years	National Institutes of Health Clinical Center (CC)
The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater	NCT02867826	Ampulla of Vate...	Cap	18 Years - 99 Years	Barretos Cancer Hospital
Comparison on the Efficacy of Endoscopic Snare Papillectomy With or Without Submucosal Injection	NCT02165852	Ampulla of Vate...	Papillectomy wi... Papillectomy wi...	18 Years -	Soon Chun Hyang University
Capecitabine and Oxaliplatin in Adenocarcinoma of the Small Bowel and Ampulla of Vater	NCT00354887	Gastrointestina...	Capecitabine Oxaliplatin	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for ampulla of vater