Study of Efficacy and Safety of Laparoscopic Intra-abdominal Chemotherapy (PIPAC) Performed in Patients With Peritoneal Carcinomatosis From Colorectal, Ovarian, Gastric Cancer and Primary Peritoneal Tumors

Phase 1/2 Completed 105 enrolled Fondazione del Piemonte per l'Oncologia

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Single center, open label, phase I-II, non-randomized, two-cohort, repeated single dose study to explore the feasibility, efficacy, safety, and Overall Response Rate (ORR) of oxaliplatin, or cisplatin and doxorubicin when given as a pressurized intraperitoneal chemotherapy (PIPAC) to patients (men and women) with peritoneal carcinomatosis from ovarian, gastric and colorectal cancers and in primary cancers of peritoneum.

Timeline

Start: 2015-10
Primary completion: 2020-05-31
Completion: 2020-05-31

Publications

Robella M, Berchialla P, Borsano A, Cinquegrana A, Ilari Civit A, De Simone M, Vaira M. Study Protocol: Phase I Dose Escalation Study of Oxaliplatin, Cisplatin and Doxorubicin Applied as PIPAC in Patients with Peritoneal Metastases. Int J Environ Res Public Health. 2021 May 25;18(11):5656. doi: 10.3390/ijerph18115656.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	7.5 mg/m2	Other
Subject	Cisplatin	Other / unclassified	15 mg/m2	Other
Subject	Cisplatin	Other / unclassified	100 mg/m2	Other
Subject	Doxorubicin	Other / unclassified	1.5 mg/m2	Other
Subject	Doxorubicin	Other / unclassified	3 mg/m2	Other
Subject	Doxorubicin	Other / unclassified	30 mg/m2	Other
Subject	Oxaliplatin	Small molecule	92 mg/m2	Other
Subject	Oxaliplatin	Small molecule	300 mg/m2	Other

Study of Efficacy and Safety of Laparoscopic Intra-abdominal Chemotherapy (PIPAC) Performed in Patients With Peritoneal Carcinomatosis From Colorectal, Ovarian, Gastric Cancer and Primary Peritoneal Tumors

Summary

Timeline

Publications

Drugs

Indications