Endoscopic Abraxane Injection Into Pancreatic Cysts - Full Text View

Purpose

This research study is a pilot study. In this pilot study we are testing the safety of a procedure. "Investigational" means that the Albumin bound paclitaxel (Abraxane) is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved Abraxane injection for your type of medical condition. Treatment of pancreatic cysts often requires follow-up imaging studies and surgical resection of the cysts. As part of standard medical care, you will be undergoing a diagnostic endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in order to evaluate type of the cyst. During the EUS and just after the cyst fluid aspiration, you will undergo the injection of the drug into the cyst cavity if your cyst is thought to be cancerous or precancerous. Cyst fluid will be analyzed for further diagnosis.

Condition	Intervention
Pancreatic Cysts	Drug: Albumin bound paclitaxel


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	EUS Guided Injection of Albumin Bound Paclitaxel Into Pancreatic Cysts

Resource links provided by NLM:

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Determine frequency of pancreatitis after injection therapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
The primary endpoint of the study will be the determination of the safety of injection of albumin-bound paclitaxel. Safety of the procedure will be measured by the frequency of pancreatitis. Laboratory testing will be performed 2 days after procedure

Secondary Outcome Measures:

Determine feasibility of EUS guided injection of albumin-bound paclitaxel into pancreatic cysts [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The feasibility of the procedure will be measured by the ease of injection of albumin-bound paclitaxel into the cyst cavity across the gastro-duodenal wall. On a subjective scale, the endoscopist will note the ease of the procedure on a scale of 0-5, with 5 being very easy and 0 is not possible. Any score less than 2 will be considered unacceptable and failure of the study.

Total procedure time will be recorded. If the cyst injection and lavage take more than 10 minutes, we will consider this a failure.
Determine the decrease in size of the cystic lesion at 3 months using CT scanning [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Determine the decrease in size of the cystic lesion at 3 months using CT scanning


Enrollment:	5
Study Start Date:	November 2012
Study Completion Date:	September 2014
Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Intervention Details:

Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.

Other Name: Abraxane

Detailed Description:

You will be asked to undergo some screening tests or procedures to find out if you can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. Screening tests include the following: medical history, performance status, assessment of pancreatic cyst by CT, MRI or EUS, blood tests and a pregnancy test.

If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria you will not be able to participate in this research study.

As part of your medical care you will be undergoing an endoscopic procedure EUS-FNA (Endoscopic Ultrasound Fine Needle Aspiration) in order to evaluate and evacuate the cyst fluid. During the EUS-FNA and just after the cyst fluid aspiration, albumin bound paclitaxel will be injected into the cyst cavity.

The study procedure (injection of drug into cyst cavity) takes place over 5 minutes during the EUS-FNA. 2 days after the procedure you will receive a phone call from the research coordinator to check on how you are feeling. 3 months after study procedure participants will undergo a follow up CT to see what happened to the cyst. You will continue to have routine follow up for your medical problems.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Mucinous cysts (premalignant or malignant cysts of the pancreas)
Normal organ and marrow function
Baseline CT within 6 months of enrollment

Exclusion Criteria:

Pregnant or breastfeeding
Acute active pancreatitis
Complicated pancreatic cysts
Subjects who do not speak English

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698710

Sponsors and Collaborators

Massachusetts General Hospital

Investigators


Principal Investigator:	William Brugge, MD	Massachusetts General Hospital

More Information


Responsible Party:	William R. Brugge, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01698710 History of Changes
Other Study ID Numbers:	12-178
Study First Received:	October 1, 2012
Last Updated:	September 17, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:


Premalignant Malignant

Additional relevant MeSH terms:


Cysts Pancreatic Cyst Neoplasms Pathological Conditions, Anatomical Pancreatic Diseases Digestive System Diseases Paclitaxel	Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 28, 2016