Endoscopic Abraxane Injection Into Pancreatic Cysts

NCT01698710 | Terminated Results DMC

• 1 other identifier: 12-178
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pancreatic Cysts

Keywords

Premalignant; Malignant

Outcome Measures

Primary Outcomes (1)

• Frequency of Pancreatitis

  Safety of injection of albumin-bound paclitaxel will be measured by the frequency of pancreatitis.

  3-10 months (median 6 months) after injection therapy

Secondary Outcomes (2)

• Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts

  immediately after procedure

• Size of Cystic Lesion

  3-10 months (median 6 months) after injection therapy

Study Arms (1)

Albumin bound paclitaxel

EXPERIMENTAL

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

Drug: Albumin bound paclitaxel

Interventions

Albumin bound paclitaxel DRUG

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

Also known as: Abraxane

Albumin bound paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Pancreatic Cyst; Precancerous Conditions

Interventions

Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. William Brugge
• Organization: Massachusetts General Hospital

Brugge.William@mgh.harvard.edu

6173083532

Study Officials

• William Brugge, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: October 3, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 21, 2017
• Results First Posted: June 21, 2017

Record last verified: 2014-09