Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan

NCT01226550 | Completed Phase 1 DMC

• 1 other identifier: 2004.368
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open, non-randomized, phase I-II, pilot study, which evaluates the combination of optimum cytoreductive surgery and hyperthermic intraoperative peritoneal chemotherapy (HIPEC) with mitomycin C (MMC) and irinotecan. The latter drug will be administered in escalating doses to patients with gastric, colorectal, appendicular, or primary peritoneal carcinosis (PC).

Conditions

Peritoneal Carcinosis (PC)

Keywords

hyperthermic intraoperative peritoneal chemotherapy (HIPEC); Irinotecan; Pharmacokinetics; peritoneal carcinomatosis (PC)

Outcome Measures

Primary Outcomes (1)

• Morbidity rate

  postoperative complications (class III and IV, Common Terminology Criteria V3; National Cancer Institute)

  30 days postoperative

Secondary Outcomes (2)

• Mortality rate

  30 days postoperative

• Intraperitoneal and serumal concentration (pharmacokinetics) of mitomycine C, irinotecan, and its metabolites.

  per-HIPEC

Study Arms (1)

cytoreductive surgery and HIPEC

EXPERIMENTAL

Procedure: cytoreductive surgery and HIPEC

Interventions

cytoreductive surgery and HIPEC PROCEDURE

The most complete cytoreductive surgery possible (ideally macroscopically complete) followed by a closed-abdomen hyperthermic intraoperative peritoneal chemotherapy (HIPEC), using a closed circuit connected to the self-regulating Cavitherm machine (EEC certified). This perfusion apparatus records temperature, flow, and pressure for 90 minutes at real temperature (42-43°C). The dialysate is made up of peritoneal dialysis fluid containing 0.7 mg/kg of MMC and increasing doses of irinotecan added to the dialysate the last 30 minutes of the HIPEC. Potentiation of irinotecan using an intravenous FUFOL perfusion at least 1hour before HIPEC (1st dose level: 10 mg/m² of folinic acid, then 200 mg/m² of 5-FU; 2nd dose level: 20 mg/m² of folinic acid, then 400 mg/m² of 5-FU).

cytoreductive surgery and HIPEC

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with a peritoneal carcinosis (PC) either of digestive origin or primary: a colorectal or gastric carcinosis, a peritoneal pseudomyxoma or mesothelioma, or a primary carcinosis of the peritoneum regardless the number of prior treatment lines.
• A PC and primary tumor considered to be resectable according to preoperative clinical and paraclinical data: absence of mesenteric retraction and absence of bladder invasion.
• Patients in good general health (ASA ≤ 2).
• Absence of cardiorespiratory failure (PaO2 \> 60 mmHg in a stable condition, dyspnea ≤ NYHA stage 1, left ventricular ejection fraction \> 60%.).
• Prothrombin level \>70 %, total bilirubin \< 2 x the normal level, ASAT and ALAT \< 2.5 x normal levels, and alkaline phosphatases \< 5 x normal levels.
• Creatinine clearance \> 60 ml/min, polynuclear neutrophils \> 1500/mm3, and a white blood cell count \> 4000 /mm3.
• Patients who give written, informed consent.
• Patients affiliated with the French universal healthcare system.

You may not qualify if:

• Patients with a PC with ovarian, mammary, biliary, pancreatic, or bronchial origin.
• Evolutive patients after systemic chemotherapy.
• Patients with a PC considered to be irresectable according to preoperative clinical and paraclinical data: mesenteric retraction or bladder invasion.
• Patients in poor general health (ASA \> 2).
• Cardiorespiratory failure (dyspnea \> NYHA stage 1, PaO2 \< 60 mmHg in a stable condition)
• Prothrombin level \< 70 %.
• Any brain abnormality showing on the head scan.
• Signs of heart failure and especially left ventricular ejection fraction \< 60% on the cardiac ultrasound.
• Thrombocytopenia \< 100 000 / mm3
• Visceral metastases other than a single resectable liver metastasis.
• Pregnancy or breast feeding.
• Chronic inflammatory intestinal disease and/or an intestinal obstruction.
• History of severe hypersensitivity to irinotecan hydrochloride trihydrate or one of the excipients of Campto.
• Bilirubinemia \> 3 times the normal upper limit
• Yellow fever vaccine.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Chirurgie Générale et Thoracique, Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

Location

Related Publications (1)

• Cotte E, Passot G, Tod M, Bakrin N, Gilly FN, Steghens A, Mohamed F, Glehen O. Closed abdomen hyperthermic intraperitoneal chemotherapy with irinotecan and mitomycin C: a phase I study. Ann Surg Oncol. 2011 Sep;18(9):2599-603. doi: 10.1245/s10434-011-1651-1. Epub 2011 Mar 19.

  PMID: 21424369 RESULT

MeSH Terms

Conditions

Peritoneal Neoplasms

Interventions

Cytoreduction Surgical Procedures; Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2010
• First Posted: October 22, 2010
• Study Start: June 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)