Endoscopic Abraxane Injection Into Pancreatic Cysts

Pancreatic Cysts Clinical Trial

Official title:

EUS Guided Injection of Albumin Bound Paclitaxel Into Pancreatic Cysts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698710
• Other study ID #: 12-178
• Status: Completed
• Phase: N/A
• First received: October 1, 2012
• Last updated: September 17, 2014
• Start date: November 2012
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cysts
• Pancreatic Cyst
• Pancreatic Cysts

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine frequency of pancreatitis after injection therapy	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	2 years	Yes
Secondary	Determine feasibility of EUS guided injection of albumin-bound paclitaxel into pancreatic cysts	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.	2 years	No
Secondary	Determine the decrease in size of the cystic lesion at 3 months using CT scanning	Determine the decrease in size of the cystic lesion at 3 months using CT scanning	2 years	No