Actively Recruiting
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) and Electrostatic PIPAC (ePIPAC) With Paclitaxel In Patients With Peritoneal Carcinomatosis
Led by National University Hospital, Singapore · Updated on 2024-05-29
36
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Peritoneal carcinomatosis (PC) is a miserable disease with poor treatment outcome. Intraperitoneal administration of anticancer drugs enables an extremely high concentration of drugs to directly contact the target cancer lesions in the peritoneal cavity. However, its effectiveness is limited by the intraperitoneal distribution and penetration of the drug. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is an innovative intraperitoneal chemotherapy concept that enhances efficacy by taking advantage of the physical properties of gas and pressure. Electrostatic precipitation pressurized intraperitoneal aerosol chemotherapy (ePIPAC) may further enhance these benefits. This research study serves to determine the safety profile and tolerability of PIPAC/ePIPAC with paclitaxel. It will determine the maximal tolerated dose (MTD) and evaluate the safety and tolerability, and pharmacokinetics of PIPAC/ePIPAC paclitaxel in pre-treated patients with peritoneal carcinomatosis (PC). It may offer a novel and effective option of treatment for patients with PC, who, at present have limited options involving the use of systemic chemotherapy and who suffer from poor life expectancy and poor quality of life.
CONDITIONS
Official Title
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) and Electrostatic PIPAC (ePIPAC) With Paclitaxel In Patients With Peritoneal Carcinomatosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of solid cancer with peritoneal metastasis confirmed by cytology or histology
- Age 21 years or older
- Completed or unable to tolerate at least first-line systemic chemotherapy
- Completed chemotherapy or targeted therapy at least 21 days or 5 half-lives before treatment
- Recovered to grade 1 or less from prior treatment toxicities
- Eastern Cooperative Oncology Group performance status 0 to 2
- Adequate bone marrow function (neutrophils 61500/mm3, hemoglobin 658.0 g/dl, platelets 65100,000/mm3)
- Adequate liver function (bilirubin 641.5x ULN, AST/ALT 643x ULN or 645x ULN if liver metastases present)
- Adequate kidney function (serum creatinine 641.5x ULN)
- Expected survival longer than 3 months
- Able to understand and willing to sign informed consent
- Agree to use effective contraception if able to have children during study participation
- Patients with treated skin cancer other than melanoma may participate
You will not qualify if you...
- Predominant cancer spread outside the peritoneum as determined by tumor board
- Evidence of or risk for hollow organ perforation (stomach, bowel, colon, gallbladder)
- Good response to systemic chemotherapy with complete or partial remission
- Known allergy to paclitaxel
- Other cancers unrelated to current disease diagnosed in last 2 years
- Refusal to use adequate contraception if able to have children
- Significant health conditions that may interfere with study participation
- Uncontrolled infections, heart failure, unstable angina, arrhythmia, psychiatric or social issues
- Pregnant or breastfeeding women
- Bowel obstruction, total dependence on parenteral nutrition, or planned gastrointestinal surgery at time of treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
National University Hospital
Singapore, Singapore, 119228
Actively Recruiting
Research Team
B
Bok Yan Jimmy So, MBChB
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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