Peritoneal Carcinosis (PC) Clinical Trial
Official title:
Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan
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).
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | April 2011 |
| Est. primary completion date | April 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 64 Years |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Service de Chirurgie Générale et Thoracique, Centre Hospitalier Lyon-Sud | Pierre Bénite Cedex |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Morbidity rate | postoperative complications (class III and IV, Common Terminology Criteria V3; National Cancer Institute) | 30 days postoperative | Yes |
| Secondary | Mortality rate | 30 days postoperative | Yes | |
| Secondary | Intraperitoneal and serumal concentration (pharmacokinetics) of mitomycine C, irinotecan, and its metabolites. | Plasma, peritoneal, and urinary values for MMC, irinotecan, SN-38, SN-38G, APC, and NPC. | per-HIPEC | Yes |