Clinical trial NCT01226550: Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan
Official title: Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Peritoneal Carcinosis (PC)
Keywords: hyperthermic intraoperative peritoneal chemotherapy (HIPEC)
Irinotecan
Pharmacokinetics
peritoneal carcinomatosis (PC)
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2010-10-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Morbidity rate
timeFrame: 30 days postoperative
Secondary outcomes:
measure: Mortality rate
timeFrame: 30 days postoperative
measure: Intraperitoneal and serumal concentration (pharmacokinetics) of mitomycine C, irinotecan, and its metabolites.
timeFrame: per-HIPEC
Other outcomes:
Locations:
city: Pierre Bénite Cedex
country: France
facility: Service de Chirurgie Générale et Thoracique, Centre Hospitalier Lyon-Sud
Study officials:
References: