Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis From Colon Cancer With Systemic FOLFOX6

This study has been completed.
Sponsor:
Collaborator:
Biocompatibles UK Ltd
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT00932438
First received: July 1, 2009
Last updated: April 17, 2013
Last verified: November 2011
  Purpose

This is a multicentre, open labeled, controlled phase study designed to assess effectiveness of chemoembolization with LC Beads, both with and without systemic chemotherapy, in the treatment of unresectable liver metastases in patients with colorectal cancer.


Condition Intervention Phase
Colon Cancer With Metastases to the Liver
Device: LC bead loaded with Irinotecan
Drug: FOLFOX6 and Avastin
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: Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis From Colon Cancer With Concomitant Systemic Oxaliplatin, Fluorouracil and Leucovorin Chemotherapy, and Anti-Angiogenic Therapy

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Tumor Response [ Time Frame: Six weeks post second TACE treatment ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: June 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Irinotecan Beads with FOLFOX6 Device: LC bead loaded with Irinotecan
Chemoembolization using LC beads loaded with 100mg Irinotecan in combination with Fluorouracil, Oxaliplatin, Leucovorin and Avastin alternating on a 2 weekly schedule
Other Name: LC Beads, TACE, FOLFOX 6
Active Comparator: FOLFOX6/Avastin alone Drug: FOLFOX6 and Avastin
Fluorouracil, Oxaliplatin, Leucovorin and Avastin given biweekly
Other Name: FOLFOX6, Liver

Detailed Description:

This is a multicentre, open labeled, prospective, randomized, controlled phase I/II study designed to assess the clinical performance of chemoembolization with LC Bead, loaded with irinotecan in combination with intravenous chemotherapy and bevacizumab versus intravenous chemotherapy in combination with bevacizumab in the treatment of unresectable liver metastases in patients with colorectal cancer.

  Eligibility

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

Inclusion:

  • Patients over 18 years of age, of any race or sex, who have histologic or radiologic proof of colorectal cancer to the liver, who are able to give informed consent, will be eligible.
  • Patients with at least one measurable liver metastases, with size > 1cm (modified RECIST criteria)
  • Patients with liver dominant disease defined as ≥80% tumor body burden confined to the liver
  • Patients with patent main portal vein
  • ECOG Performance Status score of < 2
  • Life expectancy of > 3 months
  • Non-pregnant with an acceptable contraception in premenopausal women.
  • Hematologic function: ANC ≥ 1.5 x 109/L, platelets ≥75 x109/L, INR ≤1.3* (*If patient is on anticoagulants, they must be able to stop medication temporarily prior to TACE and must have INR ≤1.3 prior to receiving TACE) Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl, Adequate Hemoglobin and Hematocrit as measured by (Male: for approximate 45 - 62%; and approximate Female: 37 - 48%) or Hemoglobin (Male: approximate 13 - 18 gm/dL Female: approximate 12 - 16 gm/dL). If patient is asymptomatic with Hemoglobin for male 10 to 12.9 or Female 9.5 to 11.9 and do not wish to be transfused they still will be eligible for treatment.
  • Adequate renal function (creatinine ≤ 2.0mg/dl)
  • Women of child bearing potential and fertile men are required to use effective contraception (negative serum βHCG for women of child-bearing age)
  • Signed, written informed consent
  • Patient is at least one month out from any treatment for Stage III colorectal cancer
  • Patient is at least one year out from any treatment for their Stage IV colorectal cancer.

    - these patients should not be candidates for curative treatments, and will have recovered from any chemotherapeutic toxicities' they may have experienced."

  • Less than 60% liver tumor replacement

Exclusion:

  • "Any 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" non-resectability includes patients with greater than 6, tumors close to blood vessels, patients with hepatic-pulmonary shunting, or patients of poor performance"
  • Active bacterial, viral or fungal infection within 72 hours of study entry
  • Women who are pregnant or breast feeding
  • Allergy to contrast media that cannot be managed with standard care (e.g. steroids), making magnetic resonance imaging (MRI) or computed tomography (CT) contraindicated.
  • Presence of another malignancy with the exception of cervical carcinoma in situ and stage I basal or squamous carcinoma of the skin.
  • 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 and that would preclude the safe use of chemoembolization or would interfere with study participation
  • Patients with prior contraindications for the use of irinotecan therapy-this would include chronic inflammatory bowel disease and or bowel obstruction, history of severe hypersensitivity reactions to irinotecan hypochloride, trihydrate, lactic acid or to any of the excipients of Camptostar, severe bone marrow failure, history of Gilbert Syndrome or concomitant use with St. John's Wort
  • Patients with prior contraindications for the use of fluorouracil, oxaliplatin, leucovorin or bevacizumab
  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: NCT00932438

Locations
United States, Alabama
Clearview Cancer Center
Huntsville, Alabama, United States, 35805
United States, California
Radiology Associates of Sacramento/Sutter Cancer Center
Sacramento, California, United States, 95816
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Northside Hospital/GA Cancer Specialists
Atlanta, Georgia, United States, 30342
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Mississippi
Hematology and Oncology Assoc. at Bridgeport
Tupelo, Mississippi, United States, 38801
United States, Missouri
Washington University/Alvin J. Siteman Cancer Center
St. Louis, Missouri, United States, 63110
United States, Oregon
Providence Portland Medical Center/Providence Cancer Center
Portland, Oregon, United States, 97213
United States, Wisconsin
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Sponsors and Collaborators
University of Louisville
Biocompatibles UK Ltd
Investigators
Study Director: Robert CG Martin, MD, PhD University of Louisville
  More Information

Additional Information:
No publications provided

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00932438     History of Changes
Other Study ID Numbers: DEBIRI # 09.0034, UL2008.1
Study First Received: July 1, 2009
Last Updated: April 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Louisville:
colon cancer
liver metastases

Additional relevant MeSH terms:
Colonic Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Fluorouracil
Oxaliplatin
Irinotecan
Bevacizumab
Leucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 23, 2014