Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) and Electrostatic PIPAC (ePIPAC) With Paclitaxel In Patients With Peritoneal Carcinomatosis

Launched by NATIONAL UNIVERSITY HOSPITAL, SINGAPORE · May 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to deliver chemotherapy directly to the abdominal cavity for patients with peritoneal carcinomatosis, a serious condition where cancer spreads to the lining of the abdomen. The treatment being tested is called Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) and its enhanced version, Electrostatic PIPAC (ePIPAC), using a drug called paclitaxel. The main goals of the trial are to find out how safe this treatment is, how well patients tolerate it, and to determine the highest dose that can be safely given.

To be eligible for this trial, participants must be at least 21 years old, have a diagnosis of solid cancer with spread to the peritoneum, and should have either completed or been unable to tolerate standard chemotherapy. They also need to be in good health overall, with specific requirements for blood and organ function. Participants can expect to receive the new treatment while being closely monitored for any side effects. It’s important to note that those who are pregnant or breastfeeding cannot participate, and both men and women of childbearing age must use effective birth control during the study. This trial could offer hope for patients who currently have limited treatment options and are facing a serious prognosis.

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Eligibility 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