INTRAPERITONEAL AEROSOLISATION OF ALBUMIN-STABILIZED PACLITAXEL NANOPARTICLES FOR PERITONEAL CARCINOMATOSIS – PHASE I/II STUDY PROTOCO

Phase 1

• Conditions: peritoneal carcinomatosis; Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-08
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

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

Inclusion Criteria

- Phase I study: patients with advanced carcinomatosis from ovarian, gastric, breast, upper GI or pancreatic origin.
- No concurrent taxane based systemic chemotherapy.
- 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
* Serum creatinine = 1.5 mg/dl or a calculated GFR (CKD-EPI) = 60 mL/min/1.73 m²
* 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
* Blood coagulation parameters within normal range
- 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

- Concurrent systemic taxane therapy until three weeks before the first experimental treatment
- 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