NCT01891552

Brief Summary

  • The recently introduced chemoembolization has been considered to be a very attractive new method in terms of response in the treatment of liver metastases from colon cancer carcinoma (LM-CRC). It appears to be particularly useful if carried out with the new embolization materials.
  • An 80% response rate was reported using TACE with Irinotecan pre-loaded Beads in patients with liver metastases from colon cancer, who had been pretreated with 2 or more lines of chemotherapy.
  • Since a greater activity was attained by a combination of Cetuximab and Irinotecan versus Cetuximab in monotherapy, the European Agency for the Evaluation of Medicinal Products (EMEA) has granted authorization to the use of Cetuximab in association with irinotecan in the treatment of irinotecan-refractory CRC-LM.
  • In this study we want to collect data on on time to progression and tolerability using DEBIRI+Cetuximab in LM-CRC

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

June 26, 2013

Last Update Submit

May 12, 2015

Conditions

Colon Cancer Liver Metastasis

Keywords

Colon Cancer, Liver Metastasis, DEBIRI, cetuximab, efficacy

Outcome Measures

Primary Outcomes (1)

  • time to progression

    one year

Secondary Outcomes (1)

  • number of adverse events

    4 months

Other Outcomes (1)

  • quality of life

    4 months

Study Arms (2)

Tacetux

DEBIRI+ CETUXIMAB ADMINISTRATION

DEBIRI

only DEBIRI treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

  • Unresectable hepatic metastases from colorectal carcinoma (CRC-LM)
  • Progression of disease after first line therapy containing Irinotecan completed at least one month previously
  • Performance status (PS) 0-2
  • Biochemistry parameters within normal limits (ALT and gamma glutamyl transpeptidase not exceeding three times the upper limit of normal, total bilirubin not exceeding 2.5 mg/ml)
  • Adequate information and subsequent written informed consent
  • Life expectancy \> 3 months
  • Patients K-RAS wild type

You may not qualify if:

  • Extension of disease greater than 50% of the parenchymal liver (confirmed by CAT scan or MRI)
  • Brain metastases
  • Severe and confirmed vascular diseases
  • Other concomitant malignancies except for cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix
  • Evidence of significant diseases such as uncontrolled diabetes, congestive heart failure, chronic renal insufficiency (CRI)
  • Known hypersensitivity reactions towards components of the study drugs
  • Pregnant or breastfeeding women or women of childbearing potential not making use of effective contraceptives
  • Family, psychological, social or geographical circumstances preventing the patient from undergoing follow-up and from complying with protocol procedures
  • Patients K-RAS mutant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore

Pesaro, PU, 61122, Italy

Location

Related Publications (2)

  • Fiorentini G, Aliberti C, Tilli M, Mulazzani L, Graziano F, Giordani P, Mambrini A, Montagnani F, Alessandroni P, Catalano V, Coschiera P. Intra-arterial infusion of irinotecan-loaded drug-eluting beads (DEBIRI) versus intravenous therapy (FOLFIRI) for hepatic metastases from colorectal cancer: final results of a phase III study. Anticancer Res. 2012 Apr;32(4):1387-95.

    PMID: 22493375RESULT

  • Guadagni S, Fiorentini G, Clementi M, Palumbo P, Mambrini A, Masedu F. Mitomycin C hypoxic pelvic perfusion for unresectable recurrent rectal cancer: pharmacokinetic comparison of surgical and percutaneous techniques. Updates Surg. 2017 Sep;69(3):403-410. doi: 10.1007/s13304-017-0480-6. Epub 2017 Aug 8.

    PMID: 28791628DERIVED

Related Links

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • GIAMMARIA FIORENTINI, MD

    International Group of Endovascular Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 26, 2013

First Posted

July 3, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 13, 2015

Record last verified: 2015-05

Locations

IT(1)