Status:
TERMINATED
Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Peritoneal Carcinomatosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To assess the efficacy of pasireotide in the reduction of clinically relevant postoperative digestive leakage after CRS plus HIPEC compared to placebo
Eligibility Criteria
Inclusion
- 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
- 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 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
Exclusion
- 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
- Patient who have already participated to this study (a patient can only be included once in the study)
- 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
Key Trial Info
Start Date :
September 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04826432
Start Date
September 3 2020
End Date
February 7 2024
Last Update
February 8 2024
Active Locations (1)
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1
Gustave Roussy
Villejuif, France, 94800