Trial Outcomes & Findings for Endoscopic Abraxane Injection Into Pancreatic Cysts (NCT NCT01698710)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

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

Results posted on

2017-06-21

Participant Flow

Participant milestones

Participant milestones
Measure	Albumin Bound Paclitaxel Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure. Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Endoscopic Abraxane Injection Into Pancreatic Cysts

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Albumin Bound Paclitaxel n=5 Participants Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure. Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
Cyst diameter	28.4 mm n=5 Participants
Location of cyst Head	4 Participants n=5 Participants
Location of cyst Body	1 Participants n=5 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Albumin Bound Paclitaxel n=5 Participants Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure. Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Frequency of Pancreatitis	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Albumin Bound Paclitaxel n=5 Participants Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure. Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts	4 units on a scale Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Albumin Bound Paclitaxel n=5 Participants Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure. Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Size of Cystic Lesion Reduction	3 Participants
Size of Cystic Lesion Persistent	1 Participants
Size of Cystic Lesion Increase	1 Participants

Adverse Events

Albumin Bound Paclitaxel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. William Brugge

Massachusetts General Hospital

Phone: 6173083532

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place