Acronym

INTERACT

Name of the study

Concomitant intraperitoneal and systemic chemotherapy in patients with extensive peritoneal carcinomatosis of colorectal origin

Researchers and contact information

Principal Investigator

Dr. J.W.A. (Pim) Burger, Catharina Ziekenhuis, Eindhoven

Catharina Hospital, Eindhoven 

Principal investigator;

Dr. J.W.A. (Pim) Burger

Coordinating Investigator

Drs. C. (Checca) Bakkers

Research Heelkunde, Postbus 1350, 5602 ZA, Eindhoven

Email: checca.bakkers@catharinaziekenhuis.nl

Phone: +31 402396350

Erasmus MC Cancer Institute, Rotterdam

Principal investigator:

Prof. dr. C. (Kees) Verhoef

Coordinating investigators:

Drs. J.P. (Job) van Kooten

Onderzoekers Heelkunde Na-21, postbus 3000, 3015 GD, Rotterdam

Email: j.kooten@erasmusmc.nl

Phone: +31 10 70 42125

R.A.G. (Ruben) van Eerden

Interne Oncologie, Translationele Farmacologie

Be-451, postbus 3000, 3015 GD, Rotterdam

Email: r.vaneerden@erasmusmc.nl

Phone: +31 10 70 39640

 

 

 

Summary study

Rationale

CRS + Hyperthermic intraperitoneal chemotherapy (HIPEC) has become standard of care for patients with peritoneal metastases of colorectal origin with a low/moderate abdominal disease load. In case of a peritoneal cancer index (PCI) above 20, CRS and HIPEC-procedure is not considered to be beneficial. These patients are often treated with systemic chemotherapy. Previous studies have shown that systemic chemotherapy is less effective against peritoneal metastases than it is for other common metastatic sites  of colorectal cancer. It is suggested that patients with peritoneal metastases may benefit from the addition of intraperitoneal chemotherapy to systemic chemotherapy. Higher concentrations of chemotherapy may persist for a longer period intraperitoneally, resulting in an increased area under the curve (AUC). This may be the first step towards a more effective, life prolonging and possibly curative treatment for this patient group.

Primary objective

To determine the maximum tolerated dose (MTD) of intraperitoneal irinotecan, added to standard of care systemic therapy (FOLFOX + bevacizumab) in patients with peritoneal metastases of colorectal origin.

Study design

Phase I, multicenter, single arm, 3+3 dose escalation study

Study population

Adult patients diagnosed with inoperable peritoneal metastases of colorectal origin.

Primary endpoint

Establish the MTD and recommended phase II dose (RP2D) of intraperitoneal irinotecan added to systemic FOLFOX and bevacizumab.

Secondary endpoints

Determine the safety and feasibility of this treatment and to establish the pharmacokinetic profile of intraperitoneally administered irinotecan.

Sample size

Dependent on outcome due to dose escalation design. Minimal number of patients is 4. Maximum number of patients is 33.

 

Intervention

According to standard work-up for CRS and 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 of the patient. Through this port we will administer intraperitoneal irinotecan (according to dose-escalation schedule), in combination with standard of care chemotherapy: systemic FOLFOX + bevacizumab.

 

Participating Centers and Investigators

Catharina Hospital, Eindhoven

Dr. J.W.A. Burger

Dr. G.J. Creemers

Erasmus MC Cancer Institute, Rotterdam

Prof. Dr. C. Verhoef

Prof. Dr. A.H.J. Mathijssen

Dr. E. van Meerten

Drs. A.R.M. Brandt-Kerkhof