CompletedPhase 1

Concomitant Intraperitoneal and Systemic Chemotherapy in Patients With Extensive Peritoneal Carcinomatosis of Gastric Origin

Netherlands20 participantsStarted 2022-05-25

Plain-language summary

Gastric cancer with peritoneal carcinomatosis has a poor prognosis, with little treatment options available. The current treatment strategy consists of palliative systemic chemotherapy. However, previous research suggests that systemic chemotherapy is less effective against peritoneal carcinomatosis than against metastases that spread hematogenously. Several studies suggested that in patients with peritoneal carcinomatosis, intraperitoneal chemotherapy (IP) may be superior compared to intravenous chemotherapy. Intraperitoneal chemotherapy could lead to higher concentrations of chemotherapy in the peritoneal cavity for a longer period of time, resulting in an increased cumulative exposure to the peritoneal metastases. A few Asian studies have shown promising results with intraperitoneal chemotherapy in patients with peritoneal carcinomatosis of gastric origin. However, intraperitoneal chemotherapy combined with systemic chemotherapy has not been investigated in Western patients with peritoneal carcinomatosis of gastric origin yet. The objective of this trial is to establish the maximum tolerated dose (MTD) of intraperitoneal administration of irinotecan, added to systemic capecitabine/oxaliplatin (CAPOX) in patients with peritoneal carcinomatosis of gastric origin.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Patients with a histologically confirmed diagnosis of HER2-negative gastric cancer. * A histologically confirmed diagnosis of peritoneal carcinomatosis. * Age ≥ 18 years old. * Written informed consent according to the ICH-GCP and national/local regulations. * A peritoneal cancer index (PCI) ≥7 evaluated by laparoscopy or laparotomy before inclusion in this trial. * Patients must be ambulatory: World Health Organisation (WHO) performance status 0 or 1. * Life expectancy of at least 3 months. * Ability to return to the Erasmus MC for adequate follow-up as required by this protocol. * Patients must have normal organ function and adequate bone marrow reserve as assessed by the following laboratory requirements: * absolute neutrophil count \>1.5 \* 10\^9/l; * platelet count \>100\*10\^9/l; * Hb\>6.0mmol/l; * Bilirubin \< 1.5x upper limit of normal (ULN); * Serum aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \< 2.5 x ULN; * Glomerular Filtration Rate (GFR) \>45 and Creatinine clearance \<2 x ULN. Exclusion Criteria: * Medical or psychological impediment to probable compliance with the protocol. * Serious concomitant disease or active infections. * Distant metastasis other than peritoneal metastasis or metastatic lymph nodes. * No sufficient oral food intake. * Polyneuropathy grade 2 or worse according to CTCAE version 5.0. * History of auto-immune disease or organ allografts, or with active or chronic infection, including…

What they're measuring

Maximum-tolerated dose

Timeframe: 18 weeks

Trial details

NCT IDNCT05379790

SponsorErasmus Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-25