Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00994110
First received: October 13, 2009
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to help us learn more about how to lower the patient's risk of the most common complications after their pancreas operation. After tumors are removed and the remaining part of the pancreas is connected to the intestine or closed, a leakage of pancreatic fluid may occur. This fluid may form an "abscess" (collection of pus) or "fistula" that would need to be drained. A fistula is a persistent leakage of pancreatic fluid that sometimes occurs after pancreatic surgery. Fistulas, leaks, and abscesses are complications that are seen in roughly every 15-20 patients out of every 100 that have pancreas surgeries. Complications like these extend the patient's stay in the hospital after surgery. These complications may require the patient's doctor to perform additional tests or procedures to treat them.

The physical and emotional burden these complications place upon patients, as well as the financial cost to the health care system, can be great. The surgeons at Memorial Sloan-Kettering Cancer Center are conducting a study to determine if a drug, SOM230, can help reduce the rate of these complications. SOM230, also known as Pasireotide, is a drug that has been observed to reduce the rate of similar complications in other studies.

The surgeon would like to compare the effects, good and/or bad, of SOM230 with "placebo" (solution without medication) to see if SOM230 reduces the rate of fistulas, leaks and abscesses.


Condition Intervention Phase
Pancreatic Cancer
Drug: Pasireotide (SOM230)
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized, Double Blind, Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To compare 60-day ≥grade 3 pancreatic complication rates (fistula, leak, and abscess) as defined by the MSKCC surgical secondary events system between patients who receive perioperative SOM230 and saline placebo. [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare the following endpoints between patients who receive perioperative SOM230 and saline placebo: 60-day overall complication rate [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • To compare the following endpoints between patients who receive perioperative SOM230 and saline placebo: 60-day overall pancreatic complication rate (grade 1-5: fistula, leak, and abscess) [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • To compare the following endpoints between patients who receive perioperative SOM230 and saline placebo: 60-day overall mortality rate [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • To compare the following endpoints between patients who receive perioperative SOM230 and saline placebo: Amylase level (drain) at the time pancreatic complication identified [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • To compare the following endpoints between patients who receive perioperative SOM230 and saline placebo: Overall duration of drainage required in patients who develop pancreatic complications (date pancreatic complication identified - date drain removed) [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • To compare the following endpoints between patients who receive perioperative SOM230 and saline placebo: Daily drain volume (cc/day) in patients with surgical drains [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • To compare the following endpoints between patients who receive perioperative SOM230 and saline placebo: Time of return of bowel function as defined by passage of flatus [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • To compare following endpoints btw pts who receive perioperative SOM230 & saline placebo:(QoL) as measured by the EORTC Core Cancer QoL Questionnaire (QLQ-C30) & the EORTC pancreatic cancer module (QLQ-PAN26) at 2 weeks & 60 days after surgery [ Time Frame: two weeks and 60 days after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: October 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOM230
This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at Memorial Sloan-Kettering Cancer Center.
Drug: Pasireotide (SOM230)

Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.

Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.

Placebo Comparator: placebo
This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at Memorial Sloan-Kettering Cancer Center.
Other: placebo

Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.

Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients aged 18 years or greater.
  • Signed informed consent
  • Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy.

Exclusion Criteria:

  • Pregnancy
  • Patients with malabsorption syndrome, short bowel or chologenic diarrhea not controlled by specific therapeutic means.
  • Patients with uncontrolled diabetes mellitus or a fasting plasma glucose > 250mg/dl.

Note: At the principle investigator's discretion, non-eligible patients can be re-screened after adequate medical therapy has been instituted.

  • Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment.
  • Patients who are at risk for QT prolongation. Risk factors include: patients with electrolyte disturbances such as hypokalemia, hypomagnesemia, and hypocalcemia; patients with a family history of long QT syndrome. syncope, and idiopathic sudden death; patients with concomitant diseases that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism, bradycardia, high-grade AV block, significant cardiac arrhythmias, or cardiac failure; patients using concomitant medications known to prolong the QT interval while receiving protocol treatment. These medications include selected antiarrhythmics, antihistamines, macrolide antibiotics, and /or tricyclic antidepressants as follows:

Albuterol Alfuzosin Amantadine Amiodarone Amitriptyline Amphetamine Arsenic Trioxide Astemizole Atazanavir Atomoxetine Azithromycin Chloroquine Clomipramine Dolasetron Metaproterenol Moxifloxacin Phenermine Phenylpropanolamine

  • Those drugs not specifically listed above but possibly suspected of causing QT prolongation would not necessarily preclude patient registration, but would be discussed with the attending physician prior to initiation of protocol therapy.
  • Patients with QTc >450 msec.
  • Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis.
  • Patients with acute cholecystitis
  • Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive HIV test result (ELISA and Western blot).
  • Patients with abnormal coagulation (INR>1.5) or patients receiving anticoagulants that affect PT (prothrombin time) or APTT ( activated thromboplastin time)
  • Patients with WBC <3 K/mcL; PLT < 100 K/mcL
  • Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator.
  • Patients who have participated in any clinical investigation with an investigational drug (other then pasireotide) within 30 days prior to dosing.
  • Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR or s.c. formulations
  • Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994110

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Novartis Pharmaceuticals
Investigators
Principal Investigator: Peter Allen, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00994110     History of Changes
Other Study ID Numbers: 09-039
Study First Received: October 13, 2009
Last Updated: September 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
PANCREAS
Pasireotide
SOM230
saline placebo
09-039

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 14, 2014