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Trial record 10 of 196 for:    colon cancer | ( Map: Colorado, United States )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00816777
Recruitment Status : Terminated (Lack of enrollment)
First Posted : January 5, 2009
Results First Posted : September 18, 2015
Last Update Posted : September 7, 2018
Biocompatibles UK Ltd
Information provided by (Responsible Party):
Generic Devices Consulting, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Unresectable Metastatic Colo-rectal Cancer Procedure: Chemoembolization with irinotecan Bead Drug: Irinotecan Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Toxicity, Adverse Events and Serious Adverse Events (NCI CTCAE v3.0) [ Time Frame: 6 weeks ]
    0 - No data collected

  2. Tumor Response (RECIST) [ Time Frame: 1 year ]
  3. Local Tumor Response (Extent of Necrosis in the Treated Lesions) [ Time Frame: 1 year ]
  4. Hepatic Progression Free Survival [ Time Frame: 1 year ]
    Data not collected - study terminated ealry

  5. Change in Tumor Marker [ Time Frame: 1 year ]
  6. Performance Status (ECOG) [ Time Frame: 1 year ]
    No data collected

  7. Overall Survival [ Time Frame: 1 year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00816777

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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
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Principal Investigator: Wells Messersmith, MD University of Colorado, Denver

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Responsible Party: Generic Devices Consulting, Inc. Identifier: NCT00816777     History of Changes
Other Study ID Numbers: CA1013
IDE G070122 ( Other Identifier: FDA IDE )
First Posted: January 5, 2009    Key Record Dates
Results First Posted: September 18, 2015
Last Update Posted: September 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Generic Devices Consulting, Inc.:
Colon Cancer
Colorectal Cancer
Gastric Cancer
Gastrointestinal Cancer
Metastatic Cancer
Metastatic Colorectal Cancer
Rectal Cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents