Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis

NCT04826432 | Terminated Phase 2 DMC

• 2 other identifiers: 2019-002507-182019/2955
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy of pasireotide in the reduction of clinically relevant postoperative digestive leakage after CRS plus HIPEC compared to placebo

Conditions

Peritoneal Carcinomatosis

Outcome Measures

Primary Outcomes (1)

• postoperative digestive leakage

  The rate of clinically relevant (NCI CTCAE v5 ≥ grade 3) postoperative digestive leakage at 97 days

  97 days

Study Arms (2)

Pasireotide

EXPERIMENTAL

0.9 mg of pasireotide subcutaneously (s.c.) twice daily (14 doses) every 12 +/- 2 hours

Drug: Pasireotide 0.9 MG/ML

Placebo

PLACEBO COMPARATOR

0.9 ml of saline water s.c. twice daily (14 doses) every 12 +/- 2 hours

Other: Saline water

Interventions

Pasireotide 0.9 MG/ML DRUG

0.9 mg of pasireotide subcutaneously (s.c.) twice daily (14 doses) every 12 +/- 2 hours

Pasireotide

Saline water OTHER

0.9 ml of saline water s.c. twice daily (14 doses) every 12 +/- 2 hours

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged between 18 years and 75 years included
• ECOG (Eastern Cooperative Oncology Group) Performance Status ≤ 2
• Primary (pseudomyxoma peritonei, peritoneal mesothelioma) or Secondary (colorectal or ovarian) peritoneal malignancies

You may not qualify if:

• Absence of extra-peritoneal metastatic disease or limited hepatic or lung metastases easily amenable to curative-intent resection or ablation
• Intraoperative Peritoneal Cancer Index (PCI score) ≥ 10
• Visceral resection with at least one digestive anastomosis with or without loop ileostomy or pancreatic or biliary resection.
• Negative serum pregnancy test for women of childbearing potential within 7 days prior to therapy
• Sexually active women of childbearing potential must agree to use a highly effective method of contraception or to abstain from sexual activity during the study and for 3 months after the last study treatment administration. Sexually active males patients must agree to use condom or to abstain from sexual activity during the study and for 3 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception during the same period.
• Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
• Patients must be affiliated to a social security system or beneficiary of the same
• Macroscopically incomplete surgical resection (CC 2)
• Standard contraindications to pasireotide:
• patients with uncontrolled diabetes mellitus or a fasting plasma glucose \> 250mg/dl (14 mMol/L)
• patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia including a corrected QT (QTc) interval longer than 450 msec, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
• patients with liver disease such as severe hepatic impairment (Child Pugh C), chronic active hepatitis or chronic persistent hepatitis with abnormal coagulation (INR\>1.5).
• patients with the presence of active or suspected acute or chronic uncontrolled infection
• hypersensitivity to somatostatin analogues or any component of pasireotide formulations
• patients with uncontrolled hypothyroidism

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Peritoneal Neoplasms

Interventions

pasireotide; Saline Waters

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Environment; Ecological and Environmental Phenomena; Biological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Single-blinded, multicentric, placebo controlled phase II comparative trial

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: September 3, 2020
• Primary Completion: February 7, 2024
• Study Completion: February 7, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

FR (1)