Pilot study on intraperitoneal chemotherapy delivered via aerosol in patients with peritoneal carcinomatosis

Phase 1

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

• Registration Number: EUCTR2020-000560-37-IT
• Lead Sponsor: ISTITUTO ONCOLOGICO VENETO - IRCCS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-21
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

- Male or female = 18 years of age
- ECOG performance status 0–2.
- Histologically or cytologically documented gastrointestinal or ovarian cancer (based on tissue from the primary tumor and/or its metastases); other cancer can be included based on a careful multidisciplinary assessment of the risk benefit of the procedure in the specific patient
- Radiological, histological or cytological evidence of peritoneal metastases
- Not eligible for curative surgery and/or HIPEC according to National Guidelines
- ife expectancy of at least 24 weeks;
- Laboratory Requirements:
- Neutrophils = 1.5 x 109/L;
- Platelets = 100 x 109/L;
- Hemoglobin = 9 g/dL;
- Total bilirubin = 1.5 time the upper-normal limits (UNL) of the normal values and ASAT (SGOT) and/or ALAT (SGPT) = 2.5 x UNL;
- Alkaline phosphatase = 2.5 x UNL;
- Creatinine clearance = 30 mL/min according to the Cockcroft-Gault formula or serum creatinine =1.5 x UNL;
- Negative serum or urine pregnancy test at screening for women of childbearing potential. Female subjects, or male subjects with female partners of child-bearing potential must be willing to use highly effective contraception as approved by the investigator (i.e. barrier contraceptive measure or oral contraception, total abstinence) during the study and until 30 days after last study treatment;
- Written informed consent to the study participation according to the Local Ethic Committee requirements before any study procedure;
- Will and ability to comply with the protocol.
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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

- Any surgery apart from staging laparoscopy less than 4 weeks before inclusion;
- Extra peritoneal metastasis; patients with limited extra peritoneal metastatic disease can be enrolled based on mdt discussion;
- Bowel obstruction or parenteral nutrition or gastric tube;
- A history of allergic reaction or contraindication to platinum containing compounds or doxorubicin;
- Any significant disease which, in the investigator’s opinion, excludes the patient from the study;
- Myocardial insufficiency, defined as NYHA class >3
- Renal impairment, defined as glomerular filtration rate (GFR) < 30 ml/min
- Impaired liver function defined as bilirubin > 1.5 UNL (except in presence of Gilbert disease)
- Pregnancy or breastfeeding;
- Untreated central nervous system disease, history or evidence of thrombotic or hemorrhagic disorders not considered currently in complete remission;
- Active infection requiring antibiotics;
- Medical, geographical, sociological, psychological, or legal conditions that would prevent the patient from completing the study or signing the informed consent;

Study & Design

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