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Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis From Colon Cancer With Concomitant Systemic Oxaliplatin, Fluorouracil and Leucovorin Chemotherapy, and Anti-Angiogenic Therapy

Phase 1/Phase 2
18 Years
Not Enrolling
Colon Cancer With Metastases to the Liver

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Trial Information

Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis From Colon Cancer With Concomitant Systemic Oxaliplatin, Fluorouracil and Leucovorin Chemotherapy, and Anti-Angiogenic Therapy

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.

Inclusion Criteria


- 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

- 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


- "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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response

Outcome Time Frame:

Six weeks post second TACE treatment

Safety Issue:


Principal Investigator

Robert CG Martin, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

University of Louisville


United States: Food and Drug Administration

Study ID:

DEBIRI # 09.0034



Start Date:

June 2009

Completion Date:

December 2012

Related Keywords:

  • Colon Cancer With Metastases to the Liver
  • colon cancer
  • liver metastases
  • Colonic Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms



Froedtert Memorial Lutheran HospitalMilwaukee, Wisconsin  53226
Emory UniversityAtlanta, Georgia  30322
University of LouisvilleLouisville, Kentucky  40202
Clearview Cancer CenterHuntsville, Alabama  35801
Radiology Associates of Sacramento/Sutter Cancer CenterSacramento, California  95816
Northside Hospital/GA Cancer SpecialistsAtlanta, Georgia  30342
Hematology and Oncology Assoc. at BridgeportTupelo, Mississippi  38801
Washington University/Alvin J. Siteman Cancer CenterSt. Louis, Missouri  63110
Providence Portland Medical Center/Providence Cancer CenterPortland, Oregon  97213