Intra-arterial Hepatic Beads Loaded With Irinotecan With Concomitant Chemotherapy With FOLFOX in Patients With Colorectal Cancer With Unresectable Liver Metastases: a Phase II Multicenter Study

NCT01839877 | Completed Phase 2 Results DMC

• 1 other identifier: FFCD 1201 DEBIRI
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 9

Brief Summary

Treatment of patients with colorectal cancer having liver metastases is currently based on systemic chemotherapy. Triple therapy with 5FU, oxaliplatin and irinotecan intravenously was effective in terms of response and secondary resectability, however it is particularly toxic. Hepatic intra-arterial chemotherapy (HIA) has been the subject of several studies. It has shown good efficacy with oxaliplatin and FUDR. However, the procedure is difficult to set up and reserved for experienced centers. The objective of this protocol is to use a triple therapy based on 5FU and oxaliplatin associated to irinotecan which is administered by hepatic intra-arterial route, loaded onto microbeads (DEBIRI). Furthermore, the procedure for chemo-embolization DEBIRI is limited to 2 sessions, and therefore could be more easily generalized.

Conditions

Colorectal Cancer With Non Resectable Hepatic Metastasis

Keywords

Metastatic colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival Rate at 9 Months

  The primary endpoint was to evaluate the rate of patients alive without progression at 9 months after the start of treatment. Events to be considered for the endpoint were: * Progression : defined as radiological progression according to RECIST V1.1 criteria, as assessed by the investigator. * Death Patients who progressed or died (from any cause) within 9 months of starting treatment were considered as failure for the primary endpoint. The first event which occured will be taken into accoun

  at 9 months after inclusion

Secondary Outcomes (1)

• Overall Survival

  up to 4 years after patient's inclusion

Study Arms (1)

HIA DEBIRI + systemic FOLFOX

EXPERIMENTAL

Intra-arterial hepatic beads loaded with irinotecan with systemic FOLFOX

Drug: HIA DEBIRI + systemic FOLFOX

Interventions

HIA DEBIRI + systemic FOLFOX DRUG

HIA DEBIRI + systemic FOLFOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven colorectal adenocarcinoma,
• Liver metastases radiologically or histologically proven
• At least one measurable liver lesions by RECIST v1.1
• Age ≥ 18 years
• WHO Index \< or = 2
• Life expectancy ≥ 3 months
• No extrahepatic disease except lung nodules if number \< or = 3 and size \< 10 mm each
• Healthy liver \<60%
• Primary tumor resected or still in place
• No prior chemotherapy for metastases treatment (except a perioperative chemotherapy, if the last cycle was administered at least 12 months ago)
• Adjuvant chemotherapy after resection of the primary authorized if the last cycle was administered at least 12 months ago
• Normal hepatic function: total bilirubin ≤ 1.5 N; AST ≤ 5N; ALT ≤ 5N and PAL ≤ 5N
• TP ≥ 60%
• Adequate hematologic function: ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, Hb ≥ 9g/dl
• Good renal function: creatinine clearance ≥ 60 mL / min

You may not qualify if:

• Patient eligible for curative treatment (resection and / or radiofrequency ablation) by a multidisciplinary decision (including the opinion of a liver surgeon)
• Pregnant or lactating woman or patients of both sexes and of childbearing age not using adequate contraception
• History of cancer, except skin cancer (other than melanoma), carcinoma in situ of the cervix uteri treated curative. Other cancers treated with curative intent are permitted provided they did not relapse over the last 5 years
• Peripheral neuropathy
• Inflammatory Bowel Diseases
• Intestinal obstruction
• Chronic liver disease (viral, alcoholic or metabolic)
• Immune Deficiency Syndromes (history of transplantation, infection with HIV)
• Known to have contraindications to 5FU, oxaliplatin, folinic acid, irinotecan or to contrast products
• Patients with known contraindications against hepatic embolization procedures:
• Presence of biliary-digestive anastomosis or biliary stent Cruoric or tumor thrombosis of the portal vein
• Patient who for psychological, social, family or geographical reasons could not be followed up regularly
• Legal disability (persons deprived of liberty or under guardianship)
• Patient is not affiliated to a social security scheme
• Participation in another concurrent study investigating the effect of treatment and this until 4 weeks after the end of the concurrent study.

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead
• Biocompatibles UK Ltd: collaborator

Study Sites (9)

Hopital Saint André

Bordeaux, 33075, France

Location

CHU - Hôpital François Mitterand

Dijon, France

Location

Hôpital Prive Jean Mermoz

Lyon, 69008, France

Location

Centre Léon Berard

Lyon, 69373, France

Location

Institut Paoli Calmette

Marseille, 13273, France

Location

CHU de la TIMONE

Marseille, 13385, France

Location

Hôpital Europeen G Pompidou

Paris, 75015, France

Location

CHU Charles Nicolle

Rouen, 76031, France

Location

Hôpital Rangueil

Toulouse, 31059, France

Location

Related Publications (1)

• Pernot S, Pellerin O, Artru P, Monterymard C, Smith D, Raoul JL, De La Fouchardiere C, Dahan L, Guimbaud R, Sefrioui D, Jouve JL, Lepage C, Tougeron D, Taieb J; for FFCD1201-DEBIRI investigators/Collaborators. Intra-arterial hepatic beads loaded with irinotecan (DEBIRI) with mFOLFOX6 in unresectable liver metastases from colorectal cancer: a Phase 2 study. Br J Cancer. 2020 Aug;123(4):518-524. doi: 10.1038/s41416-020-0917-4. Epub 2020 Jun 8.

  PMID: 32507854 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Karine Le Malicot
• Organization: Fédération Francophone de Cancérologie Digestive

karine.le-malicot@u-bourgogne.fr

+33 3 80 39 34 79

Study Officials

• Julien TAIEB, Pr

  Fédération Francophone de Cancérologie Digestive

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 25, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2019
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-07

Locations

FR (9)