NCT00844233

Brief Summary

The objective of this study is to evaluate the safety and efficacy of Irinotecan Bead in the neoadjuvant treatment (i.e. the Irinotecan Bead is administered prior to surgery) of resectable liver metastases from colorectal cancer.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2009

Typical duration for phase_1

Geographic Reach
3 countries

5 active sites

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

February 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 16, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

2.6 years

First QC Date

February 9, 2009

Last Update Submit

July 15, 2021

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Tumour resectability at surgery

    1 month

Secondary Outcomes (1)

  • Safety assessed by SAE and AE monitoring (NCI CTCAE v3.0)

    1 month

Study Arms (1)

1

EXPERIMENTAL

Irinotecan Bead

Device: Irinotecan Bead

Interventions

Irinotecan BeadDEVICE

Irinotecan eluting bead

Also known as: Irinotecan Bead, PARAGON Bead
1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of potentially resectable colorectal cancer liver metastases, with less than 60% liver tumour replacement. The consulting surgeon, according to local practice, will determine resectability.
  • Patients having undergone complete resection of the primary tumour without gross or microscopic evidence of residual disease (R0), or the primary tumour is considered R0 resectable at screening.
  • Age: 18-80 years.
  • ECOG Status ≤2.
  • No previous irinotecan-containing chemotherapy for advanced disease.
  • Previous chemotherapy is allowed (unless it contained irinotecan), but must have ended at least one month prior to study entry.
  • Presence of adequate contraception in fertile (M/F) patients. Pregnant or lactating women are excluded.
  • Absence of any other previous malignancy other than adequately treated in situ carcinoma of the cervix or non-melanoma skin cancer (unless there has been a disease-free interval of at least 10 years).
  • Patients should not have participated in another clinical trial with any investigational drug in the 30 days prior to enrolment.
  • Absence of:
  • Peripheral neuropathy (CTC \> grade 1)
  • Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia.
  • History of significant neurologic or psychiatric disorders
  • Active infection
  • Written informed consent according to ICH/EU GCP, and any applicable local, national or international regulations.
  • +7 more criteria

You may not qualify if:

  • Extrahepatic metastases constituting \>20% of tumour body burden.
  • Contraindications to irinotecan:
  • Chronic inflammatory bowel disease and/or bowel obstruction.
  • History of severe hypersensitivity reactions to irinotecan hydrochloride trihydrate.
  • Severe bone marrow failure.
  • Concomitant use with St John's Wort.
  • Active bacterial, viral or fungal infection within 72 hours of study entry.
  • Allergy to contrast media that cannot be managed with standard care.
  • Any contraindication for hepatic embolisation procedures:
  • porto-systemic shunt.
  • hepatofugal blood flow.
  • severe atheromatosis.
  • Contraindication to hepatic artery catheterisation, such as a patient with severe peripheral vascular disease precluding catheterisation.
  • Other significant medical or surgical condition, or any medication or treatment regimens, that would place the patient at undue risk, that would preclude the safe use of chemoembolisation or would interfere with study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Medical University Vienna, AKH

Vienna, 1090, Austria

Location

Centre Hépato-Biliaire, Hôpital Paul Brousse

Villejuif, 94804, France

Location

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, RG24 9NA, United Kingdom

Location

University Hospital Aintree

Liverpool, L9 7AL, United Kingdom

Location

North Manchester General Hospital

Manchester, M8 5RB, United Kingdom

Location

Related Publications (2)

  • Jones RP, Malik HZ, Fenwick SW, Terlizzo M, O'Grady E, Stremitzer S, Gruenberger T, Rees M, Plant G, Figueras J, Albiol M, Adam R, Awad S, Poston GJ. PARAGON II - A single arm multicentre phase II study of neoadjuvant therapy using irinotecan bead in patients with resectable liver metastases from colorectal cancer. Eur J Surg Oncol. 2016 Dec;42(12):1866-1872. doi: 10.1016/j.ejso.2016.07.142. Epub 2016 Aug 10.

    PMID: 27561844DERIVED

  • Jones RP, Dunne D, Sutton P, Malik HZ, Fenwick SW, Terlizzo M, O'Grady E, Koelblinger C, Stattner S, Stremitzer S, Gruenberger T, Poston GJ. Segmental and lobar administration of drug-eluting beads delivering irinotecan leads to tumour destruction: a case-control series. HPB (Oxford). 2013 Jan;15(1):71-7. doi: 10.1111/j.1477-2574.2012.00587.x. Epub 2012 Oct 16.

    PMID: 23216781DERIVED

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Professor Graeme Poston, MB, MS, FRCS

    Consultant General Surgeon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2009

First Posted

February 16, 2009

Study Start

February 1, 2009

Primary Completion

September 1, 2011

Study Completion

October 1, 2012

Last Updated

July 21, 2021

Record last verified: 2021-07

Locations

GB(3)AU(1)FR(1)