Innovative chemotherapy method for patients with peritoneal carcinomatosis
Phase 1 Study of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) and Electrostatic PIPAC (ePIPAC) With Paclitaxel for Peritoneal Carcinomatosis - PIPAC2 Study
This study is testing a new way of delivering chemotherapy directly to cancer in the abdomen to see if it is safe and works better for patients with peritoneal carcinomatosis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Sponsor | National University Hospital, Singapore Academic / other |
| Drugs / interventions | chemotherapy, Doxorubicin |
| Locations | 1 site (Singapore) |
| Trial ID | NCT05395910 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and tolerability of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) and Electrostatic PIPAC (ePIPAC) using paclitaxel in patients with peritoneal carcinomatosis. The study aims to determine the maximal tolerated dose (MTD) and evaluate the pharmacokinetics of these innovative chemotherapy techniques. By utilizing a minimally invasive approach, the trial seeks to enhance drug distribution and penetration directly to cancer lesions in the peritoneal cavity, potentially improving treatment outcomes for patients with advanced cancer. Participants will be closely monitored for safety and side effects throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21 and older with unresectable or recurrent peritoneal metastasis from solid tumors who have either refused or completed prior systemic chemotherapy.
Not a fit: Patients with resectable tumors or those who are not able to tolerate any form of chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes and quality of life for patients with peritoneal carcinomatosis.
How similar studies have performed: Previous studies have indicated that PIPAC is feasible and safe, suggesting potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All solid cancer patients with peritoneal metastasis on peritoneal cytology/histology. * Patients who refuse, are unable to tolerate, or have completed at least 1st line systemic chemotherapy * Patients who have completed chemotherapy/targeted therapy \> 21 days or at least 5 half-lives (whichever is longer) prior to PIPAC/ePIPAC * Patients must have recovered (≤ grade 1) from all reversible treatment toxicity from prior chemotherapy, radiotherapy or surgery. * Age ≥21 years * Eastern Cooperative Oncology Group performance status 0-2 * Adequate bone marrow function (neutrophil count ≥1500/mm3, hemoglobin ≥8.0 g/dl and platelet count ≥100 000/mm3) * Adequate liver function (bilirubin ≤ 1.5x ULN (upper limit normal) and AST/ALT ≤3x ULN or ≤5x ULN in the presence of liver metastases) * Adequate renal function (serum creatinine ≤1.5x ULN) * Expected survival \>3 months * Able to understand and the willingness to sign a written informed consent document * The effects of proposed regimen on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because antitumor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Patients with treated skin cancer besides melanoma may be included. Exclusion Criteria: * Predominant extra-peritoneal metastases at the discretion of the study team after discussion at the multidisciplinary tumor board * Patients with clinical or radiological evidence of hollow viscera perforation or impending perforation, including but not limited to gastric, small bowel, colon, gallbladder. Decision will be made at the discretion of the study team in consultation with multidisciplinary tumour board or with necessary specialists * Good response to systemic chemotherapy based on RECIST guidelines version 1.1 with complete or partial response to systemic chemotherapy * Known allergy to paclitaxel * Previous malignancy unrelated to current peritoneal carcinomatosis diagnosed in the last 2 years * Patients with reproductive potential who refuse to use an adequate means of contraception (including male patients) * Significant disease or conditions which, in the investigator's opinion, would exclude patient from the study * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or lactating female * Patients with bowel obstruction, total dependence on parenteral nutrition, or who are undergoing gastrointestinal resection in the same setting
Where this trial is running
Singapore
- National University Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Bok Yan Jimmy So, MBChB — National University Hospital, Singapore
- Study coordinator: Bok Yan Jimmy So, MBChB
- Email: sursbyj@nus.edu.sg
- Phone: +65 6772 5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.