Status:
RECRUITING
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) and Electrostatic PIPAC (ePIPAC) With Paclitaxel In Patients With Peritoneal Carcinomatosis
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Peritoneal Carcinomatosis
Eligibility:
All Genders
21-99 years
Phase:
PHASE1
Brief Summary
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 conta...
Detailed Description
In patients with histologically proven unresectable or recurrent gastric cancer limited to the peritoneum, the combination of intraperitoneal (IP) paclitaxel with systemic chemotherapy reported a one-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05395910
Start Date
August 4 2023
End Date
December 31 2025
Last Update
May 29 2024
Active Locations (1)
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1
National University Hospital
Singapore, Singapore, 119228