Oxaliplatin in PIPAC for Nonresectable Peritoneal Metastases of Digestive Cancers (PIPOX)
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|ClinicalTrials.gov Identifier: NCT03294252|
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : May 15, 2019
Current curative treatment of digestive peritoneal carcinomatosis consists of complete cytoreduction surgery associated with intraperitoneal chemotherapy. This treatment has important limits: a high morbimortality and the impossibility of repeating the sessions. The majority of patients are therefore treated with systemic chemotherapy, which despite its progress, remains palliative.
Pressurized Intraperitoneal aerosol chemotherapy (PIPAC) has many advantages: under laparoscopy, low morbidity, good intratumoral penetration of cytotoxics, possibility of repeating the sessions and low financial cost.
Therefore, the investigator propose a phase 1 study, in colorectal and stomach cancer, with oxaliplatin doses escalation in Pressurized Intraperitoneal aerosol chemotherapy. It would allow a better tumor response, with potentially few risks and thus improve survival in patients with digestive peritoneal carcinoses, increasing access to cytoreductive surgery.
|Condition or disease||Intervention/treatment||Phase|
|Digestive Cancer||Drug: 5-Fluorouracil Drug: L-Folinic acid Drug: Oxaliplatin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I / II Dose Escalation of Oxaliplatin Via a Laparoscopic Approach of Aerosol Pressurized Intraperitoneal Chemotherapy for Nonresectable Peritoneal Metastases of Digestive Cancers (Stomach, Hail and Colorectal)|
|Actual Study Start Date :||May 24, 2017|
|Estimated Primary Completion Date :||September 12, 2019|
|Estimated Study Completion Date :||June 7, 2021|
The experimental drugs used in this protocol are Oxaliplatin, 5-Fluorouracil and L-Folinic acid. All are used as part of their marketing authorization, with the exception of Oxaliplatin as regards its mode of administration specific to the CIPPA procedure (injection and nebulisation in intraperitoneal).
Presentation: Concentrated solution for concentrated infusion in vials containing 250 mg, 500 mg, 1 g and 5 g, in 5 ml, 10 ml, 20 ml and 100 ml respectively, providing a 50 mg / ml solution. Dosage: 400mg / m2. Administration: IV. Day of administration: between 1 h and 24 h before CIPPA.
Drug: L-Folinic acid
Presentation: lyophilisate for parenteral use, dosed at 25 mg, and in the form of a solution for injection by IM or IV dosed at 25 mg / 2.5 ml. Dosage: 20mg / m2. Administration: IV. Day of administration: between 1 h and 24 h before CIPPA.
Other Name: ELVORIN
Concentrated solution for infusion dosed with 50 mg and 100 mg. Dosage: depending on the dose range assigned to inclusion (from 90mg / m2 to 300mg / m2). Administration: the solution is packaged in a syringe which is subsequently used for injection and not in a conventional bag. The product is administered in a high-pressure injector, during the PIPAC. Day of administration : J1 of PIPAC
- maximal Tolerated Dose [ Time Frame: 8 to 12 weeks ]maximal tolerated dose 3x3 patients inclusion(modified fibonacci dose escalation)
- cumulative toxicity after the end of the CIPPA sessions received (maximum 5) at the same dose level [ Time Frame: 24 months ]with CTC-AE scale
- overall survival [ Time Frame: 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294252
|Contact: DUMONT Frederic, MD||+33 2 40 67 99 firstname.lastname@example.org|
|Contact: DEBEAUPUIS Emilie||+33 2 40 67 99 email@example.com|
|Centre Hospitalier Lyon Sud||Recruiting|
|Pierre-Bénite, France, 69495|
|Contact: Naoual BAKRIN, MD firstname.lastname@example.org|
|ICO René Gauducheau||Recruiting|
|Saint-Herblain, France, 44805|
|Contact: DUMONT Frédéric, MD +33 2 40 67 99 00 email@example.com|
|Principal Investigator:||DUMONT Frederic, MD||Institut de Cancérologie de l'Ouest|