Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan
Phase 1
Completed
- Conditions
- Peritoneal Carcinosis (PC)
- Interventions
- Procedure: cytoreductive surgery and HIPEC
- Registration Number
- NCT01226550
- Lead Sponsor
- Hospices Civils de Lyon
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description cytoreductive surgery and HIPEC cytoreductive surgery and HIPEC -
- Primary Outcome Measures
Name Time Method Morbidity rate 30 days postoperative postoperative complications (class III and IV, Common Terminology Criteria V3; National Cancer Institute)
- Secondary Outcome Measures
Name Time Method Mortality rate 30 days postoperative Intraperitoneal and serumal concentration (pharmacokinetics) of mitomycine C, irinotecan, and its metabolites. per-HIPEC Plasma, peritoneal, and urinary values for MMC, irinotecan, SN-38, SN-38G, APC, and NPC.
Trial Locations
- Locations (1)
Service de Chirurgie Générale et Thoracique, Centre Hospitalier Lyon-Sud
🇫🇷Pierre Bénite Cedex, France