Peritoneal carcinomatosis Colorectal cancer Intraperitoneal chemotherapy
Conditions
Interventions
According to standard work-up for HIPEC-procedure, patients will undergo a planned diagnostic laparoscopy to score the PCI. In case of a PCI >20, a peritoneal access port will be placed in the abdomen
Sponsors
Erasmus Medical Center Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Patients with a histologically confirmed diagnosis of colorectal cancer • Radiologically or clinically confirmed diagnosis of peritoneal carcinomatosis • Age ≥ 18 years old • Written informed consent according to the ICH-GCP and national/local regulations • Unknown PCI for which a DLS is planned in the work-up for a HIPEC-procedure OR known PCI >20 evaluated by laparoscopy or laparotomy before inclusion in this trial • Patients must be ambulatory, WHO performance status 0 or 1 (Appendix A) • Life expectancy of at least 3 months • Ability to return to the Erasmus MC/Catharina Hospital 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: o absolute neutrophil count >1.5 * 10^9/l o platelet count >100*10^9/l o Hb>6.0mmol/l o Bilirubin 45 and Creatinine clearance <2 x ULN
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Extra-abdominal disease/metastatic disease established by preoperative CT-scan of thorax-abdomen and/or PET-scan. Imaging not older than one months at time of surgery • Prior cytoreductive surgery • Prior treatment with systemic chemotherapy for (metastatic) colorectal cancer within the last 6 months • Medical or psychological impediment to probable compliance with the protocol • Serious concomitant disease or active infections • History of auto-immune disease or organ allografts, or with active or chronic infection, including HIV and viral hepatitis • Serious intercurrent chronic or acute illness such as pulmonary (COPD or asthma) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the study coordinator to constitute an unwarranted high risk for participation in this study • Homozygous UGT1A1*28 genotype • Homozygous or (compound) heterozygous DPYD genotype (tested for *2A, *13, 2846A>T, and 1236G>A) • Current use of strong CYP3A4-inhibitors or inducers. If patients use this CYP3A4-modulating medication, it is allowed to stop it within 14 days of start of treatment • Pregnant or lactating women • Concomitant participation in another competing clinical study • Absence of assurance of compliance with the protocol • An organic brain syndrome or other significant psychiatric abnormality which would comprise the ability to give informed consent, and preclude participation in the full protocol and follow-up
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are to explore the safety and feasibility of this treatment and to establish the pharmacokinetic profile of intraperitoneal administered irinotecan. During this study we will also collect and store ascites for (future) translational research purposes. | — |
Primary
| Measure | Time frame |
|---|---|
| This project will establish the maximum tolerable dose and recommended phase II dose of intraperitoneal irinotecan added to systemic FOLFOX + bevacizumab. | — |
Contacts
Public Contactdrs. Nadine de Boer
Erasmus MC Kanker Instituut
Outcome results
None listed