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

Civil Hospices of Lyon

Status and phase

Completed

Phase 2

Phase 1

Conditions

Peritoneal Carcinosis (PC)

Treatments

Procedure: cytoreductive surgery and HIPEC

Study type

Interventional

Funder types

Other

Identifiers

NCT01226550

2004.368

Details and patient eligibility

About

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).

Enrollment

18 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.
Prophylactic treatment with phenytoin.
Severe medullary insufficiency.