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

NCT ID: NCT01839877

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2019-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HIA DEBIRI + systemic FOLFOX

Intra-arterial hepatic beads loaded with irinotecan with systemic FOLFOX

Group Type: EXPERIMENTAL

HIA DEBIRI + systemic FOLFOX

Intervention Type: DRUG

Interventions

HIA DEBIRI + systemic FOLFOX

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• No cardiac dysfunction: no cardiovascular events in the last 6 months or no NYHA ≥ 2

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocompatibles UK Ltd

INDUSTRY

Sponsor Role: collaborator

Federation Francophone de Cancerologie Digestive

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julien TAIEB, Pr

Role: PRINCIPAL_INVESTIGATOR

Fédération Francophone de Cancérologie Digestive

Locations

Hopital Saint André

Bordeaux, , France

CHU - Hôpital François Mitterand

Dijon, , France

Hôpital Prive Jean Mermoz

Lyon, , France

Centre Léon Berard

Lyon, , France

Institut Paoli Calmette

Marseille, , France

CHU de la TIMONE

Marseille, , France

Hôpital Europeen G Pompidou

Paris, , France

CHU Charles Nicolle

Rouen, , France

Hôpital Rangueil

Toulouse, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 32507854 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

FFCD 1201 DEBIRI

Identifier Type: -

Identifier Source: org_study_id