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

NCT ID: NCT04826432

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-03
• Study Completion Date: 2024-02-07

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pasireotide

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

Group Type: EXPERIMENTAL

Pasireotide 0.9 MG/ML

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Saline water

Intervention Type: OTHER

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

Interventions

Pasireotide 0.9 MG/ML

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

Intervention Type: DRUG

Saline water

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

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

• Macroscopically incomplete surgical resection (CC 2)
• Standard contraindications to pasireotide:

1. patients with uncontrolled diabetes mellitus or a fasting plasma glucose > 250mg/dl (14 mMol/L)

2. 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

3. 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).

4. patients with the presence of active or suspected acute or chronic uncontrolled infection

5. hypersensitivity to somatostatin analogues or any component of pasireotide formulations

6. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gustave Roussy

Villejuif, , France

Countries

France

Other Identifiers

2019/2955

Identifier Type: OTHER

Identifier Source: secondary_id

2019-002507-18

Identifier Type: -

Identifier Source: org_study_id