Know Cancer

or
forgot password

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


Phase 1/Phase 2
18 Years
64 Years
Not Enrolling
Both
Peritoneal Carcinosis (PC)

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Morbidity rate

Outcome Description:

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

Outcome Time Frame:

30 days postoperative

Safety Issue:

Yes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2004.368

NCT ID:

NCT01226550

Start Date:

June 2007

Completion Date:

April 2011

Related Keywords:

  • Peritoneal Carcinosis (PC)
  • hyperthermic intraoperative peritoneal chemotherapy (HIPEC)
  • Irinotecan
  • Pharmacokinetics
  • peritoneal carcinomatosis (PC)
  • Fever
  • Carcinoma

Name

Location