A Phase 1/2 interventional study of 5-Fluorouracil and L-Folinic acid in Digestive Cancer, sponsored by Institut Cancerologie de l'Ouest. Terminated at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Institut Cancerologie de l'Ouest · Phase 1/2, Interventional, and Treatment
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.
The objective of this study is to determine the maximum tolerated dose (mtd) of oxaliplatin to be used during PIPAC.
Study design is a phase I/II, multicentre, non-comparative, non-randomised dose escalation clinical trial.
The phase I study will consist of a 3 by 3 dose escalation according to modified fibonacci dose escalation, starting at the current PIPAC dose (i.e. 90mg/m2), up to a maximum dose of 300mg/m2, corresponding to the current Intraperitoneal chemohyperthermia.
Each patient may receive up to 5 PIPAC sessions ; DLT period will be from the first day (D1) of the first PIPAC session until the end of the second PIPAC session, including the interval chemotherapy (i.e. D-1 of the 3rd CIPPA session), i.e. 4 to 6 weeks later ; Phase II study is an extension cohort at the recommended dose determined in the Phase I study. It will be a multi-centre, single-arm study and will analyse overall patient survival and secondary resectability rates with complete cytoreductive surgery and intraperitoneal chemohyperthermia. It will be conducted in approximately 20 patients treated at the recommended dose and followed for 2 years.
Exclusion Criteria:
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 PIPAC procedure (injection and nebulisation in intraperitoneal).
Drug: 5-Fluorouracil · Drug: L-Folinic acid · Drug: Oxaliplatin
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 PIPAC.
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 PIPAC.
Also known as: 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
Maximal tolerated dose 3x3 patients inclusion(modified fibonacci dose escalation)
Time frame: 8 to 12 weeks
Recommanded dose for the extension phase
Dose level below the maximum tolerated dose
Time frame: 8 to 12 weeks
Cumulative toxicity after the end of the PIPAC sessions received (maximum 5) at the same dose level
with CTC-AE scale
Time frame: 24 months after the last PIPAC received
Overall survival
Median overall survival at the end of the study
Time frame: 24 months after the last PIPAC received
Progression-Free Survival
Median PFS, time between the first PIPAC received and progression or death in absence of progression
Time frame: 12 months after the last PIPAC received
This study is terminated, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Institut Cancerologie de l'Ouest