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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

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ClinicalTrials.gov Identifier: NCT01839877
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : December 23, 2020
Sponsor:
Collaborator:
Biocompatibles UK Ltd
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer With Non Resectable Hepatic Metastasis Drug: HIA DEBIRI + systemic FOLFOX Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Irinotecan

Arms and Interventions
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Arm Intervention/treatment
Experimental: HIA DEBIRI + systemic FOLFOX
Intra-arterial hepatic beads loaded with irinotecan with systemic FOLFOX
 Drug: HIA DEBIRI + systemic FOLFOX


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival rate at 9 months [ Time Frame: at 9 months after inclusion ]

Secondary Outcome Measures :
  1. safety of the study treatment [ Time Frame: at 9 months after inclusion ]
    Adverse event rate; all grade, grades 1-2 and grades 3-4

  2. Overall survival [ Time Frame: 2 years after last patient in ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839877


Locations
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France
Hopital Saint André
Bordeaux, France, 33075
CHU - Hôpital François Mitterand
Dijon, France
Hôpital Prive Jean Mermoz
Lyon, France, 69008
Centre Léon Berard
Lyon, France, 69373
Institut Paoli Calmette
Marseille, France, 13273
CHU de la TIMONE
Marseille, France, 13385
Hôpital Europeen G Pompidou
Paris, France, 75015
CHU Charles Nicolle
Rouen, France, 76031
Hôpital Rangueil
Toulouse, France, 31059
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Biocompatibles UK Ltd
Investigators
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Principal Investigator: Julien TAIEB, Pr Fédération Francophone de Cancérologie Digestive
More Information
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Publications of Results:

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Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT01839877    
Other Study ID Numbers: FFCD 1201 DEBIRI
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
Keywords provided by Federation Francophone de Cancerologie Digestive:
Metastatic colorectal Cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes