Chemoembolization, Irinotecan Bead, Second Line Chemotherapy Treatment of Unresectable Metastatic Colorectal Cancer (PARAGON)

This study has been terminated.
(Lack of enrollment)
Sponsor:
Collaborator:
Biocompatibles UK Ltd
Information provided by (Responsible Party):
Generic Devices Consulting, Inc.
ClinicalTrials.gov Identifier:
NCT00816777
First received: January 2, 2009
Last updated: March 11, 2012
Last verified: March 2012
  Purpose

The primary objective of this study is to evaluate the safety and efficacy of Irinotecan Bead in combination with intravenous chemotherapy versus intravenous chemotherapy alone in the treatment of unresectable liver metastases in patients with colorectal cancer. The results of this study are intended to be used in support of a PMA application for a combination device


Condition Intervention Phase
Unresectable Metastatic Colo-rectal Cancer
Procedure: Chemoembolization with irinotecan Bead
Drug: Irinotecan
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility and Prospective Randomized Study of Transarterial Chemoembolization Using Irinotecan Bead in Combination With Second Line Chemotherapy in the Treatment of Patients With Unresectable Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Generic Devices Consulting, Inc.:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity, Adverse events and Serious Adverse Events (NCI CTCAE v3.0) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Tumor response (RECIST) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Local Tumor Response (extent of necrosis in the treated lesions) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Hepatic Progression Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in tumor marker [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Performance Status (ECOG) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: December 2008
Study Completion Date: March 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemoembolization
Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)
Procedure: Chemoembolization with irinotecan Bead
Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule
Other Names:
  • Trans arterial Chemoembolization
  • Irinotecan Bead
Drug: Irinotecan
Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks
Other Name: camptosar
Active Comparator: Chemotherapy
Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks
Drug: Irinotecan
Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks
Other Name: camptosar

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with confirmed diagnosis of stage IV colorectal cancer with unresectable liver metastases (primary tumor may be present)
  • Patients with at least one measurable liver metastases, with size > 1cm (RECIST criteria)
  • Patients with liver dominant disease defined as ≥50% tumor body burden confined to the liver
  • Patients with patent main portal vein
  • Performance status ≤ 2 ECOG
  • Life expectancy > 6 months
  • Aged ≥18 years
  • Patient has failed (discontinued for progression or toxicity) one prior line of chemotherapy for metastatic disease, preferably oxaliplatin-based (e.g. FOLFOX, CAPOX). Note that substitutions of oral versus IV 5-FU formulations, changes in 5-FU schedules, or discontinuations/re-starting of the same chemotherapy drugs will not be considered as separate lines of therapy, nor will the addition of "biologics" such as bevacizumab, cetuximab, or panitumumab
  • Patient has no previous treatment with irinotecan
  • At least 4 weeks since last administration of last chemotherapy and /or radiotherapy
  • Hematologic function: ANC ≥ 1.5 x 109/L, platelets ≥75 x10-9/L, INR <1.5 (patients on therapeutic anticoagulants are not eligible)
  • Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl,
  • Adequate renal function (creatinine ≤ 2.0mg/dl)
  • Women of child bearing potential and fertile men are required to use effective contraception (negative serum βHCG/urine test for women of child-bearing age)
  • Signed, written informed consent

Exclusion Criteria:

  • Patient eligible for curative treatment (i.e. resection or radiofrequency ablation). Note: resectability is defined as a single tumor <5cm with adequate liver function defined: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl
  • Contraindications to irinotecan:
  • Chronic inflammatory bowel disease and/or bowel obstruction
  • History of severe hypersensitivity reactions to irinotecan hydrochloride trihydrate, lactic acid or to any of the excipients of Camptosar
  • Severe bone marrow failure
  • History of Gilbert Syndrome (specific testing not required)
  • Concomitant use with St John's Wort (Hypericum)
  • Active bacterial, viral or fungal infection within 72 hours of study entry
  • Women who are pregnant or breast feeding
  • Previous irinotecan based therapy for metastatic disease
  • Patients' whose only measurable disease is within an area of the liver previously subject to radiotherapy
  • Allergy to contrast media that cannot be managed with standard care (e.g. steroids)
  • Presence of another malignancy with the exception of cervical carcinoma in situ and stage I basal or squamous carcinoma of the skin
  • Contraindicated for MRI or CT
  • Patients previously treated with transarterial embolization (with or without chemotherapy)
  • Any contraindication for hepatic embolization procedures:
  • Large shunt as determined by the investigator (pretesting with TcMMA not required)
  • Severe atheromatosis
  • Hepatofugal blood flow
  • Main portal vein occlusion (e.g. thrombus or tumor)
  • Other significant medical or surgical condition, or any medication or treatment, that would place the patient at undue risk, that would preclude the safe use of chemoembolization 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: NCT00816777

Locations
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Generic Devices Consulting, Inc.
Biocompatibles UK Ltd
Investigators
Principal Investigator: Wells Messersmith, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: Generic Devices Consulting, Inc.
ClinicalTrials.gov Identifier: NCT00816777     History of Changes
Other Study ID Numbers: CA1013, IDE G070122
Study First Received: January 2, 2009
Last Updated: March 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Generic Devices Consulting, Inc.:
Cancer
Carcinoma
Colon Cancer
Colorectal Cancer
Gastric Cancer
Gastrointestinal Cancer
Metastases
Metastatic Cancer
Metastatic Colorectal Cancer
Oncology
Rectal Cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic 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 21, 2014