Study of Chemoembolisation Using Irinotecan Bead Prior to Surgery in Metastatic Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

— PARAGON-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00844233
• Other study ID #: CA1016
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 2009
• Est. completion date: October 2012

Study information

• Verified date: July 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Device:
• Irinotecan Bead
Irinotecan eluting bead

Locations

Country	Name	City	State
Austria	Medical University Vienna, AKH	Vienna
France	Centre Hépato-Biliaire, Hôpital Paul Brousse	Villejuif
United Kingdom	Basingstoke and North Hampshire NHS Foundation Trust	Basingstoke
United Kingdom	University Hospital Aintree	Liverpool
United Kingdom	North Manchester General Hospital	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	Biocompatibles UK Ltd

Countries where clinical trial is conducted

Austria,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumour resectability at surgery		1 month
Secondary	Safety assessed by SAE and AE monitoring (NCI CTCAE v3.0)		1 month

External Links

•   Sponsor company website