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

This study has been completed.
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 3, 2014
Last verified: September 2014

October 13, 2009
September 3, 2014
October 2009
September 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00994110 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess
Prospective Randomized, Double Blind, Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Pancreatic Cancer
  • 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.

  • 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.

  • 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.
    Intervention: Drug: Pasireotide (SOM230)
  • 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.
    Intervention: Other: placebo
Allen PJ, Gönen M, Brennan MF, Bucknor AA, Robinson LM, Pappas MM, Carlucci KE, D'Angelica MI, DeMatteo RP, Kingham TP, Fong Y, Jarnagin WR. Pasireotide for postoperative pancreatic fistula. N Engl J Med. 2014 May 22;370(21):2014-22. doi: 10.1056/NEJMoa1313688.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
438
September 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00994110
09-039
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Novartis Pharmaceuticals
Principal Investigator: Peter Allen, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP