Endoscopic Abraxane Injection Into Pancreatic Cysts

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
William R. Brugge, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01698710
First received: October 1, 2012
Last updated: October 28, 2013
Last verified: October 2013
  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:


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


Estimated Enrollment: 10
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Albumin bound paclitaxel
    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
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

Contacts
Contact: William Brugge, MD 6177243715 wbrugge@partners.org
Contact: Mustafa Atar, MD 6177240462 matar@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: William Brugge, MD    617-724-3715    wbrugge@partners.org   
Principal Investigator: William Brugge, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: William Brugge, MD Massachusetts General Hospital
  More Information

No publications provided

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: October 28, 2013
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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014