Study of Chemoembolisation Using Irinotecan Bead Prior to Surgery in Metastatic Colorectal Cancer (PARAGON-II)

July 15, 2021 updated by: Boston Scientific Corporation

A Single Arm Phase II Study of Neoadjuvant Therapy Using Irinotecan Bead in Patients With Resectable Liver Metastases From Colorectal Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Primary Endpoint of this study is Tumour resectability at surgery. Secondary Endpoints:

  1. Safety assessed by SAE and AE monitoring (NCI CTCAE v3.0)
  2. Tumour response assessed by imaging (RECIST and necrosis)
  3. Viable residual tumour assessed by pathological evaluation of resected liver tissue.
  4. Recurrence (time and site) following resection
  5. Correlation of tumour response by imaging and pathology

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University Vienna, AKH
  • France
      • Villejuif, France, 94804
        • Centre Hépato-Biliaire, Hôpital Paul Brousse
  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9NA
        • Basingstoke and North Hampshire NHS Foundation Trust
      • Liverpool, United Kingdom, L9 7AL
        • University Hospital Aintree
      • Manchester, United Kingdom, M8 5RB
        • North Manchester General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  1. 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.
  2. 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.
  3. Age: 18-80 years.
  4. ECOG Status ≤2.
  5. No previous irinotecan-containing chemotherapy for advanced disease.
  6. Previous chemotherapy is allowed (unless it contained irinotecan), but must have ended at least one month prior to study entry.
  7. Presence of adequate contraception in fertile (M/F) patients. Pregnant or lactating women are excluded.
  8. 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).
  9. Patients should not have participated in another clinical trial with any investigational drug in the 30 days prior to enrolment.

  10. 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
  11. Written informed consent according to ICH/EU GCP, and any applicable local, national or international regulations.
  12. Patients with liver-dominant disease, defined as ≥80% of the tumour body burden confined to the liver. Unilobar disease, or bilobar disease suitable for treatment in a single chemoembolisation procedure, with a maximum of 4 lesions.
  13. Hematologic function: WBC ≥3.0 x 10*9/L, platelets ≥100 x 10*9/L, Absolute neutrophil count > 1.5 x 10*9/l.

  14. Adequate organ function as measured by:

    1. Serum creatinine ≤2 x upper limit of normal (ULN).
    2. Serum transaminases (AST & ALT) ≤5 x ULN.
    3. Total bilirubin ≤1.5 x ULN.
    4. Prothrombin time >50% of normal.

Exclusion criteria

  1. Extrahepatic metastases constituting >20% of tumour body burden.

  2. Contraindications to irinotecan:

    1. Chronic inflammatory bowel disease and/or bowel obstruction.
    2. History of severe hypersensitivity reactions to irinotecan hydrochloride trihydrate.
    3. Severe bone marrow failure.
    4. Concomitant use with St John's Wort.
  3. Active bacterial, viral or fungal infection within 72 hours of study entry.
  4. Allergy to contrast media that cannot be managed with standard care.

  5. Any contraindication for hepatic embolisation procedures:

    1. porto-systemic shunt.
    2. hepatofugal blood flow.
    3. severe atheromatosis.
  6. Contraindication to hepatic artery catheterisation, such as a patient with severe peripheral vascular disease precluding catheterisation.
  7. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Irinotecan Bead
Device: Irinotecan Bead
Irinotecan eluting bead
Other Names:
  • Irinotecan Bead, PARAGON Bead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumour resectability at surgery
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety assessed by SAE and AE monitoring (NCI CTCAE v3.0)
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Collaborators

Biocompatibles UK Ltd

Investigators

  • Principal Investigator: Professor Graeme Poston, MB, MS, FRCS, Consultant General Surgeon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

February 9, 2009

First Submitted That Met QC Criteria

February 13, 2009

First Posted (ESTIMATE)

February 16, 2009

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA1016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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