INTRAPERITONEAL AEROSOLISATION OF ALBUMIN-STABILIZED PACLITAXEL NANOPARTICLES FOR RECURRENT GI AND OVARIAN CANCER – PHASE I/II STUDY PROTOCO

Phase 1

• Conditions: Recurrent gastrointestinal and ovarian cancer; MedDRA version: 20.0Level: LLTClassification code 10068069Term: Peritoneal carcinomatosisSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-001688-20-DK
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-17
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

-Phase I study: patients with advanced carcinomatosis from ovarian, gastric, or pancreatic origin. No alternative systemic treatment options are available.
-Phase II study: platinum resistant or refractory recurrent ovarian cancer or primary peritoneal carcinoma, FIGO stage IIIB or C.
-Selected stage IV patients with very limited metastatic disease are eligible for inclusion
-Age over 18 years
-Adequate performance status (Karnofsky index > 60%)
-Absence of intestinal or urinary obstruction
-Limited size of the majority of peritoneal tumor implants (< 5 mm)
-Absent or limited ascites
-Ability to understand the proposed treatment protocol and provide informed consent
-Expected life expectancy more than 6 months
-Laboratory data
oSerum creatinine = 1.5 mg/dl or a calculated GFR (CKD-EPI) = 60 mL/min/1.73 m2
oSerum total bilirubin = 1.5 mg/dl, except for known Gilbert’s disease
oPlatelet count > 100.000/µl
oHemoglobin > 9g/dl
oNeutrophil granulocytes > 1.500/ml
oInternational Normalized Ratio (INR) = 2
-Absence of alcohol and/or drug abuse
-No other concurrent malignant disease
-Written informed consent
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 53
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

-Pregnancy or breast feeding. Women who can become pregnant must ensure effective contraception.
-Active bacterial, viral or fungal infection
-Active gastro-duodenal ulcer
-Parenchymal liver disease (any stage cirrhosis)
-Uncontrolled diabetes mellitus
-Psychiatric pathology affecting comprehension and judgement faculty
-General or local (abdominal) contra-indications for laparoscopic surgery
-Documented intolerance or allergy to paclitaxel (Taxol or Abraxane)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the safety and efficacy of IV Taxol combined with repeated pressurized intraperitoneal aerosol therapy (PIPAC) using albumin bound nanoparticle paclitaxel (nab-pac, Abraxane) in a multicentre, multinational phase I/II trial.;Secondary Objective: not applicable;Primary end point(s): Phase I: Maximally tolerated dose of Abraxane, administered every four weeks using intraperitoneal laparoscopy-assisted aerosolisation (PIPAC).<br>Phase II: Progression free survival, measured from the day of randomization.;Timepoint(s) of evaluation of this end point: Phase I: after every study drug administration<br>Phase II: from the day of randomization until the end of study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Phase I: <br>-Surgical morbidity and mortality of laparoscopy<br>-Technical failure rate<br>-Pathological response rate<br>-Pharmacokinetic/Pharmacodynamic analysis<br>-Quality of life at 3,6,9, and 12 months<br>Phase II: <br>-Surgical morbidity and mortality of laparoscopy<br>-Technical failure rate<br>-Pathological response rate<br>-Overall survival<br>-Disease free survival;Timepoint(s) of evaluation of this end point: - All endpoints: after each visit until end of study<br>- Quality of life at 3, 6, 9, and 12 months after first study drug administration