Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan
This study has been completed.
Sponsor:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01226550
First received: October 20, 2010
Last updated: December 28, 2011
Last verified: December 2011
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Peritoneal Carcinosis (PC) |
Procedure: cytoreductive surgery and HIPEC |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan |
Resource links provided by NLM:
Further study details as provided by Hospices Civils de Lyon:
Primary Outcome Measures:
- Morbidity rate [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]postoperative complications (class III and IV, Common Terminology Criteria V3; National Cancer Institute)
Secondary Outcome Measures:
- Mortality rate [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]
- Intraperitoneal and serumal concentration (pharmacokinetics) of mitomycine C, irinotecan, and its metabolites. [ Time Frame: per-HIPEC ] [ Designated as safety issue: Yes ]Plasma, peritoneal, and urinary values for MMC, irinotecan, SN-38, SN-38G, APC, and NPC.
| Enrollment: | 18 |
| Study Start Date: | June 2007 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: cytoreductive surgery and HIPEC |
Procedure: cytoreductive surgery and HIPEC
The most complete cytoreductive surgery possible (ideally macroscopically complete) followed by a closed-abdomen hyperthermic intraoperative peritoneal chemotherapy (HIPEC), using a closed circuit connected to the self-regulating Cavitherm machine (EEC certified). This perfusion apparatus records temperature, flow, and pressure for 90 minutes at real temperature (42-43°C). The dialysate is made up of peritoneal dialysis fluid containing 0.7 mg/kg of MMC and increasing doses of irinotecan added to the dialysate the last 30 minutes of the HIPEC. Potentiation of irinotecan using an intravenous FUFOL perfusion at least 1hour before HIPEC (1st dose level: 10 mg/m² of folinic acid, then 200 mg/m² of 5-FU; 2nd dose level: 20 mg/m² of folinic acid, then 400 mg/m² of 5-FU). |
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT01226550 History of Changes |
| Other Study ID Numbers: | 2004.368 |
| Study First Received: | October 20, 2010 |
| Last Updated: | December 28, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Hospices Civils de Lyon:
|
hyperthermic intraoperative peritoneal chemotherapy (HIPEC) Irinotecan Pharmacokinetics peritoneal carcinomatosis (PC) |
Additional relevant MeSH terms:
|
Fever Carcinoma Body Temperature Changes Signs and Symptoms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Mitomycins Mitomycin Irinotecan Antibiotics, Antineoplastic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013