Primary and secondary peritoneal malignancies MedDRA version: 20.0 Level: LLT Classification code 10068069 Term: Peritoneal carcinomatosis System Organ Class: 100000004864 MedDRA version: 20.1 Level: PT Classification code 10080244 Term: Peritoneal cancer index System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Signifor 0.9mg solution for injection
Product Name: Pasireotide
Pharmaceutical Form: Solution for injection
INN or Proposed INN: pasireotide
CAS Number: 396091-73-9
Other descriptive name:
Sponsors
Gustave Roussy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients aged 18 years or greater • ECOG (Eastern Cooperative Oncology Group) Performance Status = 2 • Primary (pseudomyxoma peritonei, peritoneal mesothelioma) or Secondary (colorectal or ovarian) peritoneal malignancies • Curative intent resection obtained by a complete resection according to the Completeness of Cytoreduction score (CC) (CC 0-1) followed by HIPEC Different intraperitoneal drug administration modalities such as neoadjuvant systemic plus simultaneous intraperitoneal and intravenous chemotherapy (NIPS) or pressurized intra-peritoneal aerosol chemotherapy (PIPAC) does not represent exclusion criteria. • 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 • 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 163 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
Exclusion criteria: • 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 • Patients participating or who have participated to another study evaluating the effect of a new drug other than pasireotide within 1 month prior to dosing • 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. • Women who are pregnant or likely to be so, or who are breastfeeding • Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of pasireotide in the reduction of clinically relevant postoperative digestive leakage after CRS plus HIPEC compared to placebo;Secondary Objective: Compare between the two arms: 1. secretion-absorption digestive balance 2. postoperative outcomes 3. overall and disease-free survival 4. safety profile and feasibility of treatment ;Primary end point(s): The rate of clinically relevant (NCI CTCAE v5 = grade 3) postoperative digestive leakage at 97 days;Timepoint(s) of evaluation of this end point: 90 days after the end of treatment (=J97) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Nasogastric output, duration of postoperative ileus, early functional results • Overall and severe complication, length of hospital stay • Overall and disease-free survivals • Safety and feasibility ;Timepoint(s) of evaluation of this end point: During Long-Term follow up : in maximum 3 years. | — |
Countries
France
Contacts
Public ContactSponsor CRA
Gustave Roussy
Outcome results
None listed