Clinical Trials

Surgery

Research Study Opened: January 2014

H28324:  “A Randomized Prospective Multicenter Trial of Pancreas Resection With and Without Routine Intraperitoneal Drainage

 PI: John Allendorf / Coordinator: Barbara Moskowitz ANP-C

Medical Oncology

Adjuvant (Stage II patients)

RTOG-0848 Phase II evaluating both Erlotinib and Chemoradiation as Adjuvant Treatment for patients with resected head of pancreas adenocarcinoma

Metastatic (Stage IV patients)

S1115 SWOG Randomized phase II Trial of AZD6244 hydrogen Sulfate and MK-2206 vs mFolfox in patients with metastatic pancreatic cancer after prior chemotherapy

Novel tumor Markers (all stages)

Tumor marker study the CA72.4 comparing it to the standard tumor markers and Recist criteria.

Biliary Endoscopy

EGBD study –  Endoscopic Ultrasound (EUS)-Guided Biliary Drainage in Patients with Inoperable Malignant Distal Biliary Obstruction and Failed ERCP:  A Prospective Feasibility Multicenter Trial

Inclusion Criteria

  1. Consecutive adult patients (18-80 years of age) with jaundice due to inoperable (by EUS and/or CT criteria or due to health status) malignant distal (more than 2cm distal to hilum) biliary obstruction and who have failed prior ERCP attempt. Failure is considered to be 2 unsuccessful attempts, according to each institution’s definition of “failed” procedure (patients may be consented for EGBD prior to repeat ERCP due to higher likelihood of failure). One failure at outside institution and one failure at our institution can be considered as total of two failures.
  2. Patients who are willing and able to give informed consent.

Exclusion Criteria

  1. Unable or not willing to give informed consent
  2. Life expectancy < 1month
  3. Pregnant or breastfeeding women
  4. Acute gastrointestinal bleeding
  5. Coagulopathy defined by prothrombin time < 50% of control; PTT > 50 sec, or INR > 1.5), on chronic anticoagulation, or platelet count <50,000
  6. Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy
  7. Prior total gastrectomy, Roux-en-Y gastric bypass, esophagectomy and sleeve gastrectomy
  8. Cirrhosis with portal hypertension, varices, and/or ascites
  9. Liver metastases burden > 30%

Endoscopic Ultrasound Guided Liver Biopsy: a Multicenter Experience 

Inclusion Criteria

1. Patients 18 years or older, male or female, belonging to any race or ethnic origin who require EGD/EUS and also liver biopsy

2. Patients who are willing and competent to sign Informed Consent

Exclusion Criteria  

1.  Patients who are below 18 years of age

2.  Significant coagulopathy with INR greater than 1.5, or platelets less than 50, 000.

3.  Pregnancy or suspected pregnancy

4.  Patients with a contraindication to upper GI endoscopy and deep sedation

5.  Recent or current use of clopidogrel, aspirin, Coumadin within 7 days

6.  Patients who are not in need of both an EGD/EUS and a liver biopsy

7.  Patients who, in the investigator’s opinion, are medically unstable, are unable to give informed consent, or whose risks outweigh the benefits of participating in the study

8.  Vulnerable subjects: Prisoners, persons with decisional incapacity, and any person who are directly involved in the study, including their immediate family members, and anybody who may have any conflict of interest.

DATE:  08/30/13

RE:  PROTOCOL UPDATE LIST

GI TRIALS:                          

RTOG – 0848 (CTSU)  A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma

PI: Dr. Hindenburg  / Coordinator: Christine Stanganelli

IRB #:  11003

  • Histologic proof of primary head of pancreas
  • AJCC 6th edition of pathologic stage T1-T3, NO-1, MO
  • Surgery 21-56 days before registration

Opened: 1/20/11

S1115:  “Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate

(NSC-748727) and MK-2206 (NSC-749607) vs mFOLFOX in Patients with

Metastatic Pancreatic Cancer After Prior Chemotherapy.”

 PI: Alexander Hindenburg, MD / Coordinator: Christine Stanganelli

ACCRUAL :  2

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