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Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer (PIPAC-NAL-IRI)

Primary Purpose

Peritoneal Carcinomatosis, Peritoneal Metastases, Colorectal Cancer

Status

Recruiting

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

PIPAC with Nal-IRI

About this trial

This is an interventional treatment trial for Peritoneal Carcinomatosis focused on measuring PIPAC, Nal-IRI, Peritoneal carcinomatosis, dose-finding study, pharmacokinetics, pharmacodynamics, safety and efficacy, Onivyde, Primary gastrointestinal cancer, Colorectal cancer, Small bowel cancer, Appendix cancer, Stomach cancer, Pancreatic cancer, Cholangiocarcinoma, dose-escalation study, Peritoneal metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Biopsy proven cancer of the pancreas, gallbladder or biliary tract, stomach, small bowel, colon, rectum, or appendix with extensive or irresectable peritoneal carcinomatosis
Estimated life expectancy > 6 months; > 3 months if primary cancer is pancreatic
Age ≥ 18 years
Adequate performance status (Karnofsky index > 60% and WHO performance status < 2)
Written informed consent obtained prior any act of the research

Exclusion Criteria:

Concomitant systemic (IV) treatment with irinotecan (either as monotherapy or as part of a combination regimen such as FOLFIRI, CAPIRI, or FOLFOXIRI)
Pregnancy or breastfeeding during the clinical study
Patients of childbearing age unable or unwilling to provide effective contraception during the study and until the end of relevant exposure (extended by 30 days (female participants) or 120 days (male participants) since the IMP is genotoxic).
Known allergy or intolerance to irinotecan
Significant amount of ascites detectable (exceeding 3l in volume)
Intestinal or urinary tract obstruction
Extensive hepatic and/or extra-abdominal metastatic disease
Impaired renal function (serum creatinine > 1.5 mg/dl or calculated GFR (CKD-EPI) < 60 mL/min/1.73 m²
Impaired liver function (serum total bilirubin > 1.5 mg/dl, except for known Gilbert's disease)
Platelet count < 100.000/µl
Hemoglobin < 9g/dl
Neutrophil granulocytes < 1.500/ml
Patients known to use:
- CYP3A4 inducers (rifampin, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, St John's wort)
- inhibitors of CYP3A4 (clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (atazanavir, gemfibrozil, indinavir, regorafenib)

Sites / Locations

UZ GhentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Nal-IRI (Onivyde) - 30mg/m²

Nal-IRI (Onivyde) - 45mg/m²

Nal-IRI (Onivyde) - 60mg/m²

Nal-IRI (Onivyde) - 75mg/m²

Nal-IRI (Onivyde) - 90mg/m²

Arm Description

PIPAC with Onivyde (30 mg/m²) will be administered every 4 to 6 weeks for 3 cycles.

PIPAC with Onivyde (45 mg/m²) will be administered every 4 to 6 weeks for 3 cycles.

PIPAC with Onivyde (60 mg/m²) will be administered every 4 to 6 weeks for 3 cycles.

PIPAC with Onivyde (75 mg/m²) will be administered every 4 to 6 weeks for 3 cycles.

PIPAC with Onivyde (90 mg/m²) will be administered every 4 to 6 weeks for 3 cycles.

Outcomes

Primary Outcome Measures

Maximally tolerated dose (MTD) of Nal-IRI

Dose limiting toxicities will be monitored.

Secondary Outcome Measures

Recommended phase 2 dose

Define the dose recommended to use in a follow-up phase 2 trial based on incidence of DLT and toxicity data scored with CTCAE v5.0 for chemotherapy related toxicity.

Surgical morbidity will be measured

This will be estimated with the Dindo-Clavien classification and the comprehensive complication index (CCI).

Maximum concentration (Cmax) of nanoliposomal irinotecan

Determined for CPT-11, SN-38 and SN-38G in plasma and tumor tissue using UPLC-MS/MS.

Time to reach maximum concentration (Tmax) of nanoliposomal irinotecan

Determined for CPT-11, SN-38 and SN-38G in plasma and tumor tissue using UPLC-MS/MS.

Area under the curve (AUC0h-24h) of nanoliposomal irinotecan

Determined for CPT-11, SN-38 and SN-38G in plasma and tumor tissue using UPLC-MS/MS.

Volume of distribution (Vd) of nanoliposomal irinotecan

Determined for CPT-11, SN-38 and SN-38G in plasma and tumor tissue using UPLC-MS/MS.

Clearance (Cl) of nanoliposomal irinotecan

Determined for CPT-11, SN-38 and SN-38G in plasma and tumor tissue using UPLC-MS/MS.

Elimination half-life (T1/2) of nanoliposomal irinotecan

Determined for CPT-11, SN-38 and SN-38G in plasma and tumor tissue using UPLC-MS/MS.

Pharmacodynamics (PD) of nanoliposomal irinotecan will be analysed with the Peritoneal regression grading score (PRGS)

Evaluated on tumor biopsies to determine histological treatment response

Pharmacodynamics (PD) of nanoliposomal irinotecan will be analysed by tumor biopsies.

Tumour samples will be collected at the end of the aerosol delivery after each PIPAC procedure.

Time-to-event endpoints

To evaluate patient's follow-up, several time-to-event endpoints are recorded which include: overall survival (OS), progression free survival (PFS) and peritoneal progression free survival (PPFS).

Quality of Life (The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QLQ-C30)

This will be investigated using the EORTC QLQ-C30 questionnaire. As to question 1 to 28: the scale varies from 1 (not at all) to 4 (very much). A higher value indicates a lower quality of life. The total score will be between 28 and 112. The scale of question 29 and 30 varies from 1 (very poor) to 7 (excellent). The higher the value, the better the quality of life. The total score will be between 2 and 14

Quality of Life (Functional Assessment of Cancer Therapy, FACT-G questionnaire)

This will be investigated using the FACT-G questionnaire. The scale of all questions varies from 0 (not at all) to 4 (very much). The total score will be between 0 and 108. The lower the total score, the better the quality of life.

Quality of Life (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) score)

This will be investigated using the PRO-CTCAE™ questionnaire. The scale of all questions varies from 0 to 4 or 0 to 1 representing absent/present. PRO-CTCAE scores for each attribute (frequency, severity and/or interference) should be presented descriptively (eg. summary statistics or graphical presentations).

Pain assessment performed by patient (Visual Analog Scale (VAS), Pain )

With this score, pain is assessed on a horizontal line, 100 mm in length, anchored by word descriptors at each end, no pain and very severe pain respectively. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left-hand end of the line to the point that the patient marks.

Overall treatment response

Determined according to the RECIST criteria, if possible (measurable lesions on CT or MRI). When no target lesions available, overall treatment response (stable disease, partial response, or progressive disease) will be determined by incorporating PRGS, clinical signs and symptoms, tumor markers, imaging findings (other than target lesions, e.g. ascites volume).

Full Information

NCT ID

NCT05277766

First Posted

February 18, 2022

Last Updated

July 14, 2023

Sponsor

University Hospital, Ghent

Collaborators

Kom Op Tegen Kanker, University Ghent

1. Study Identification

Unique Protocol Identification Number

NCT05277766

Brief Title

Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer

Acronym

PIPAC-NAL-IRI

Official Title

Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer: a Phase I Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 21, 2022 (Actual)

Primary Completion Date

August 2025 (Anticipated)

Study Completion Date

January 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Ghent

Collaborators

Kom Op Tegen Kanker, University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The PIPAC NAL-IRI study is designed to examine the maximal tolerated dose of nanoliposomal irinotecan (Nal-IRI, Onivyde) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC), in a monocentric, phase I trial.

Detailed Description

Peritoneal metastases (PM) are a common manifestation of gastrointestinal cancer. The prognosis of patients with PM is particularly poor, and response to systemic chemotherapy is worse compared to parenchymal metastatic cancer in the liver or lungs. In addition, patients with PM frequently develop debilitating symptoms such as intractable ascites, bowel obstruction, or ureteric obstruction, resulting in a severely compromised quality of life. In selected patients with widespread PM, pressurized intraperitoneal aerosol chemotherapy (PIPAC) holds considerable promise. Briefly, PIPAC combines laparoscopy with intraperitoneal (IP) administration of chemotherapy as an aerosol, which is generated by a nebulizer. The pharmacokinetic (PK) and clinical advantages of PIPAC may be further enhanced by using nanosized anticancer drugs. Nal-IRI (Onivyde) is a nanoliposomal formulation of irinotecan (Camptothecin-11 (CPT-11)), with a markedly superior efficacy when compared with free CPT-11 in human breast and colon cancer xenograft models. This is a phase I clinical study with aerosolized IP Nal-IRI in patients with PM from GI cancer. In this phase I study, dose escalation will be combined with pharmacokinetic/pharmacodynamic modelling which incorporates, in addition to plasma, tumour tissue, and peritoneal drug concentrations, biomarkers of toxicity and efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peritoneal Carcinomatosis, Peritoneal Metastases, Colorectal Cancer, Small Bowel Cancer, Appendix Cancer, Gastric Cancer, Pancreatic Cancer, Bile Duct Cancer

Keywords

PIPAC, Nal-IRI, Peritoneal carcinomatosis, dose-finding study, pharmacokinetics, pharmacodynamics, safety and efficacy, Onivyde, Primary gastrointestinal cancer, Colorectal cancer, Small bowel cancer, Appendix cancer, Stomach cancer, Pancreatic cancer, Cholangiocarcinoma, dose-escalation study, Peritoneal metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

Phase I study with dose escalation according to two-stage time-to-event continual reassessment method (TITE-CRM): 3x30 - 3x45 - 4x60 - 4x 75 - 16x90 mg/m2 (number of patients x assigned dose). Dose escalation is continued until dose-limiting toxicity (DLT) is observed. Only DLTs that take place within 14 weeks of the start of the treatment are considered. From that moment, TITE-CRM updates an initial prior estimate of the probabilities of DLT based on all available information, including patients with incomplete follow-up. Newly accrued patients are assigned the dose whose estimated probability of DLT at that time is closest to target probability. This method allows for continuous, staggered accrual of patients. The target-probability of DLT is 30%. The estimated MTD will be the dose whose estimated posterior probability of DLT is closest to that targeted probability.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nal-IRI (Onivyde) - 30mg/m²

Arm Type

Experimental

Arm Description

PIPAC with Onivyde (30 mg/m²) will be administered every 4 to 6 weeks for 3 cycles.

Arm Title

Nal-IRI (Onivyde) - 45mg/m²

Arm Type

Experimental

Arm Description

PIPAC with Onivyde (45 mg/m²) will be administered every 4 to 6 weeks for 3 cycles.

Arm Title

Nal-IRI (Onivyde) - 60mg/m²

Arm Type

Experimental

Arm Description

PIPAC with Onivyde (60 mg/m²) will be administered every 4 to 6 weeks for 3 cycles.

Arm Title

Nal-IRI (Onivyde) - 75mg/m²

Arm Type

Experimental

Arm Description

PIPAC with Onivyde (75 mg/m²) will be administered every 4 to 6 weeks for 3 cycles.

Arm Title

Nal-IRI (Onivyde) - 90mg/m²

Arm Type

Experimental

Arm Description

PIPAC with Onivyde (90 mg/m²) will be administered every 4 to 6 weeks for 3 cycles.

Intervention Type

Drug

Intervention Name(s)

PIPAC with Nal-IRI

Other Intervention Name(s)

Onivyde

Intervention Description

Nanoliposomal irinotecan (Nal-IRI, Onivyde) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 30 to 90 mg/m². PIPAC will be performed every 4 to 6 weeks for 3 cycles.

Primary Outcome Measure Information:

Title

Maximally tolerated dose (MTD) of Nal-IRI

Description

Dose limiting toxicities will be monitored.

Time Frame

Within 14 weeks of the start of the treatment

Secondary Outcome Measure Information:

Title

Recommended phase 2 dose

Description

Define the dose recommended to use in a follow-up phase 2 trial based on incidence of DLT and toxicity data scored with CTCAE v5.0 for chemotherapy related toxicity.

Time Frame

6 months after last subject's third PIPAC

Title

Surgical morbidity will be measured

Description

This will be estimated with the Dindo-Clavien classification and the comprehensive complication index (CCI).

Time Frame

6 months after third PIPAC

Title

Maximum concentration (Cmax) of nanoliposomal irinotecan

Description

Determined for CPT-11, SN-38 and SN-38G in plasma and tumor tissue using UPLC-MS/MS.

Time Frame

Plasma at 10 timepoints: T= pre-dose (0 minutes=start nebulization), T=30 minutes, T=1.5 hour, T=2.5 hours, T=6 hours, T=24 hours, T=72 hours, T=168 hours, T=336 hours, T=504 hours // Tissue: T= pre-dose (0 minutes=start nebulization), T = 30 minutes

Title

Time to reach maximum concentration (Tmax) of nanoliposomal irinotecan

Description

Determined for CPT-11, SN-38 and SN-38G in plasma and tumor tissue using UPLC-MS/MS.

Time Frame

Title

Area under the curve (AUC0h-24h) of nanoliposomal irinotecan

Description

Determined for CPT-11, SN-38 and SN-38G in plasma and tumor tissue using UPLC-MS/MS.

Time Frame

Title

Volume of distribution (Vd) of nanoliposomal irinotecan

Description

Determined for CPT-11, SN-38 and SN-38G in plasma and tumor tissue using UPLC-MS/MS.

Time Frame

Title

Clearance (Cl) of nanoliposomal irinotecan

Description

Determined for CPT-11, SN-38 and SN-38G in plasma and tumor tissue using UPLC-MS/MS.

Time Frame

Title

Elimination half-life (T1/2) of nanoliposomal irinotecan

Description

Determined for CPT-11, SN-38 and SN-38G in plasma and tumor tissue using UPLC-MS/MS.

Time Frame

Title

Pharmacodynamics (PD) of nanoliposomal irinotecan will be analysed with the Peritoneal regression grading score (PRGS)

Description

Evaluated on tumor biopsies to determine histological treatment response

Time Frame

T= pre-dose (0 minutes= start nebulization)

Title

Pharmacodynamics (PD) of nanoliposomal irinotecan will be analysed by tumor biopsies.

Description

Tumour samples will be collected at the end of the aerosol delivery after each PIPAC procedure.

Time Frame

T= 30 minutes

Title

Time-to-event endpoints

Description

To evaluate patient's follow-up, several time-to-event endpoints are recorded which include: overall survival (OS), progression free survival (PFS) and peritoneal progression free survival (PPFS).

Time Frame

12 months after last subjects last visit

Title

Quality of Life (The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QLQ-C30)

Description

Time Frame

Pre-operatively (every PIPAC), week 2 (every PIPAC) and, at 3 months, 6months and 12 months after last PIPAC procedure

Title

Quality of Life (Functional Assessment of Cancer Therapy, FACT-G questionnaire)

Description

Time Frame

Pre-operatively (every PIPAC), week 2 (every PIPAC) and, and at 3 months, 6months and 12 months after last PIPAC procedure

Title

Quality of Life (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) score)

Description

Time Frame

Determined before each PIPAC, every 14th day after PIPAC and at 3 months, 6months and 12 months after last PIPAC procedure

Title

Pain assessment performed by patient (Visual Analog Scale (VAS), Pain )

Description

Time Frame

Determined before each PIPAC procedure, one day postoperatively, and one week after the procedure.

Title

Overall treatment response

Description

Time Frame

Determined 8 months after last subject last visit

Other Pre-specified Outcome Measures:

Title

Exploratory outcome: DNA topoisomerase I (TOP-1) gene copy number

Description

This will be determined in plasma and tissue samples. This outcome evaluates anti-cancer efficacy.

Time Frame

8 months after last subject last visit

Title

Exploratory outcome: Expression of human carboxylesterase 2 (hCE2)

Description

This will be determined in plasma and tissue samples. This outcome evaluates conversion of CPT-11 to SN-38 between patients.

Time Frame

8 months after last subject last visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Biopsy proven cancer of the pancreas, gallbladder or biliary tract, stomach, small bowel, colon, rectum, or appendix with extensive or irresectable peritoneal carcinomatosis Estimated life expectancy > 6 months; > 3 months if primary cancer is pancreatic Age ≥ 18 years Adequate performance status (Karnofsky index > 60% and WHO performance status < 2) Written informed consent obtained prior any act of the research Exclusion Criteria: Concomitant systemic (IV) treatment with irinotecan (either as monotherapy or as part of a combination regimen such as FOLFIRI, CAPIRI, or FOLFOXIRI) Pregnancy or breastfeeding during the clinical study Patients of childbearing age unable or unwilling to provide effective contraception during the study and until the end of relevant exposure (extended by 30 days (female participants) or 120 days (male participants) since the IMP is genotoxic). Known allergy or intolerance to irinotecan Significant amount of ascites detectable (exceeding 3l in volume) Intestinal or urinary tract obstruction Extensive hepatic and/or extra-abdominal metastatic disease Impaired renal function (serum creatinine > 1.5 mg/dl or calculated GFR (CKD-EPI) < 60 mL/min/1.73 m² Impaired liver function (serum total bilirubin > 1.5 mg/dl, except for known Gilbert's disease) Platelet count < 100.000/µl Hemoglobin < 9g/dl Neutrophil granulocytes < 1.500/ml Patients known to use: CYP3A4 inducers (rifampin, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, St John's wort) inhibitors of CYP3A4 (clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (atazanavir, gemfibrozil, indinavir, regorafenib)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wim P Ceelen, MD, PhD, Prof

Phone

+3293326251

wim.ceelen@ugent.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wim P Ceelen, MD, PhD, Prof

Organizational Affiliation

University Hospital, Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

UZ Ghent

City

Ghent

State/Province

East-Flanders

ZIP/Postal Code

9000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wim P Ceelen, MD, PhD, Prof

Phone

+3293326251

wim.ceelen@ugent.be

First Name & Middle Initial & Last Name & Degree

Wouter Willaert, MD, PhD, Prof

Phone

+3293328950

wouter.willaert@ugent.be

12. IPD Sharing Statement

Plan to Share IPD

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Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer

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