Clinical Trial 23999

• Overview

  Study Title:

  A Randomized Phase III Blinded Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula

  Summary:

  This phase III trial compares the effect of using lanreotide before surgery to surgery alone in preventing pancreatic fistulas in patients with pancreatic cancer or a pancreatic lesion that could become cancerous. Lanreotide, a type of somatostatin analog similar to somatostatin (a hormone made by the body), and is used to treat certain types of gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome. It may help stop the body from making extra amounts of certain hormones, including growth hormone, insulin, glucagon, and hormones that affect digestion. It may also help keep certain types of tumor cells from growing. Patients with pancreatic cancer or pancreatic lesions may undergo surgery to remove parts of the pancreas, also called a distal pancreatectomy. Patients may experience complications after surgery, including pancreatic fistulas. A pancreatic fistula occurs when there is a small leak from the pancreas, causing fluids to collect. This can often lead to infection and other problems. Giving lanreotide before undergoing distal pancreatectomy may be more effective than surgery alone in preventing the development of a pancreatic fistula in patients with pancreatic cancer or a pancreatic lesion that could become cancerous.

  Objective:

  Primary Objective * To compare the incidence of postoperative pancreatic fistula (POPF) occurring within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo prior to undergoing distal pancreatectomy for biopsy-proven or suspected neoplasm. Secondary Objective(s) * To compare the incidence of International Study Group of Pancreatic Surgery (ISGPS)-defined Biochemical Leak occurring within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo in the subset of participants with a drain placed. * To compare the number of postoperative days in the hospital within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo. * To compare change from baseline in cancer-specific quality of life at 14 and 60 days after surgery, as measured by the EORTC QLQ-C30, in participants randomized to receive preoperative lanreotide versus placebo.

• Treatments

  Therapies:

  Growth hormone inhibitor

  Medications:

  Lanreotide/Placebo ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Participants must have histologically or radiographically confirmed diagnosis of pancreatic cancer or a pancreatic lesion with malignant potential.
  • Participants must have an elective distal pancreatectomy planned to occur within 60 days after registration/randomization date.
  • Participants must not have a known history of a prior diagnosis of malabsorption syndrome.
  • Participants must not have been treated with any somatostatin analogue within 180 days prior to registration/randomization.
  • Participants must not have been treated with radiation therapy for their pancreas malignancy at any time prior to registration/randomization.
  • Participants must not have been treated with peptide receptor radionuclide therapy (PRRT) at any time prior to registration/randomization.
  • Participants must be ≥ 18 years old.
  • Participants must have a complete documented medical history and physical exam within 28 days prior to registration/randomization.
  • Participants must have a creatinine ≤ the institutional upper limit of normal (IULN) OR a measured OR calculated creatinine clearance ≥ 50 mL/min using the following Cockcroft -Gault formula within 60 days prior to registration/randomization.
  • Participants must complete a pre-registration screening to identify any of the medications below, allowing the study team and treating physician to develop a monitoring plan as needed. Participants taking medications with known interactions with lanreotide may remain eligible if appropriate monitoring and management are in place.
  • In the opinion of the treating surgeon, based on preoperative data, the participant must not require a modified Appleby-type procedure (distal pancreatectomy with celiac axis resection) or multivisceral resection (e.g., stomach, colon, etc.) at the time of distal pancreatectomy.
  • In the opinion of the treating surgeon, based on preoperative data, the participant must not require a tumor enucleation.
  • Participants must not have moderate to severe hepatic impairment as defined by liver enzyme elevation more than 5 times the institutional upper limit of normal (either aspartate aminotransferase [AST] > 190 U/L or alanine aminotransferase [ALT] > 320 U/L) within 60 days prior to registration/randomization. Transient elevation at the time of screening that resolves prior to study enrollment is acceptable.
  • Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped).
  • Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during the whole period of the study and for three months after the study drug administration, with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.
  • Participants must be offered the opportunity to participate in specimen banking
  • Additional criteria may apply.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Not meeting all of the inclusion criteria.

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