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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biocompatibles UK Ltd
ClinicalTrials.gov Identifier:
NCT00844233
First received: February 9, 2009
Last updated: March 28, 2013
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Metastatic Colorectal Cancer
Device: Irinotecan Bead
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm Phase II Study of Neoadjuvant Therapy Using Irinotecan Bead in Patients With Resectable Liver Metastases From Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Biocompatibles UK Ltd:

Primary Outcome Measures:
  • Tumour resectability at surgery [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety assessed by SAE and AE monitoring (NCI CTCAE v3.0) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: February 2009
Study Completion Date: October 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Irinotecan Bead
Device: Irinotecan Bead
Irinotecan eluting bead
Other Name: Irinotecan Bead, PARAGON Bead

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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844233

Locations
Austria
Medical University Vienna, AKH
Vienna, Austria, 1090
France
Centre Hépato-Biliaire, Hôpital Paul Brousse
Villejuif, France, 94804
United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, United Kingdom, RG24 9NA
University Hospital Aintree
Liverpool, United Kingdom, L9 7AL
North Manchester General Hospital
Manchester, United Kingdom, M8 5RB
Sponsors and Collaborators
Biocompatibles UK Ltd
Investigators
Principal Investigator: Professor Graeme Poston, MB, MS, FRCS Consultant General Surgeon
  More Information

Additional Information:
No publications provided by Biocompatibles UK Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biocompatibles UK Ltd
ClinicalTrials.gov Identifier: NCT00844233     History of Changes
Other Study ID Numbers: CA1016
Study First Received: February 9, 2009
Last Updated: March 28, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014