Concomitant intraperitoneal and systemic chemotherapy in patients with extensive peritoneal carcinomatosis of colorectal origi
- Conditions
- Colon Cancer with metastasis in the peritoneumPeritoneal carcinomatosis of colorectal origin100346521002747610017998
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 33
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
protocol)
* 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 < 1.5x upper limit of normal (ULN)
o Serum AST and ALT < 2.5 x ULN
o GFR>45 and Creatinine clearance <2 x ULN
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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 6 weeks 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
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Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome is the MTD and recommended phase II dose of intraperitoneal<br /><br>irinotecan</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary outcomes are the safety and feasibility of this treatment and to<br /><br>establish the pharmacokinetic profile of intraperitoneal administered<br /><br>irinotecan</p><br>