Endoscopic Abraxane Injection Into Pancreatic Cysts
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ClinicalTrials.gov Identifier: NCT01698710 |
Recruitment Status :
Terminated
(expiration of IRB approval)
First Posted : October 3, 2012
Results First Posted : June 21, 2017
Last Update Posted : June 21, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pancreatic Cysts | Drug: Albumin bound paclitaxel | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | EUS Guided Injection of Albumin Bound Paclitaxel Into Pancreatic Cysts |
Study Start Date : | November 2012 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Albumin bound paclitaxel
Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
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Drug: Albumin bound paclitaxel
Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Other Name: Abraxane |
- Frequency of Pancreatitis [ Time Frame: 3-10 months (median 6 months) after injection therapy ]Safety of injection of albumin-bound paclitaxel will be measured by the frequency of pancreatitis.
- Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts [ Time Frame: immediately after procedure ]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.
- Size of Cystic Lesion [ Time Frame: 3-10 months (median 6 months) after injection therapy ]Determine the size of the cystic lesion using CT scanning. Number of participants with reduction in size, persistent size, or increase in size of cyst are reported.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698710
Principal Investigator: | William Brugge, MD | Massachusetts General Hospital |
Responsible Party: | William R. Brugge, MD, Principal Investigator, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01698710 |
Other Study ID Numbers: |
12-178 |
First Posted: | October 3, 2012 Key Record Dates |
Results First Posted: | June 21, 2017 |
Last Update Posted: | June 21, 2017 |
Last Verified: | September 2014 |
Premalignant Malignant |
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 |