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Phase II Study of Drug-eluting Irinotecan Beads (DEBIRI) in Refractory Metastatic Colorectal Cancer With Liver-only or Liver-predominant Disease

Phase 2
18 Years
Not Enrolling
Liver Metastases, Mucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Signet Ring Adenocarcinoma of the Colon, Signet Ring Adenocarcinoma of the Rectum, Stage IV Colon Cancer, Stage IV Rectal Cancer

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Trial Information

Phase II Study of Drug-eluting Irinotecan Beads (DEBIRI) in Refractory Metastatic Colorectal Cancer With Liver-only or Liver-predominant Disease


I. To define the response rate of colorectal liver metastases (in the treated lobe) treated
with DEBIRI, in refractory mCRC patients.


I. To evaluate the time to progression in the treated lobe for this patient population.

II. To evaluate the overall survival for this patient population. III. To evaluate patient
tolerance and the toxicity profile of treatment with DEBIRI in this patient population.


Patients receive irinotecan-eluting beads via hepatic artery embolization every 3 weeks for
up to 3 (unilobar disease) or 4 (bi-lobar disease) courses in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3
months for 2 years.

Inclusion Criteria


- Patients must have a histologically or cytologically confirmed adenocarcinoma of the
colon or rectum that is metastatic to the liver and for which standard curative
measures do not exist

- Patients must have received prior irinotecan-based treatment for their disease and
had documented progression by RECIST criteria; patients must also have received prior
fluoropyrimidine and oxaliplatin-based therapy

- Liver disease must not be amenable to potentially curative surgical resection

- Patients must have liver-only or liver-predominant disease to be eligible for this
study; hepatic disease must be dominant, but patients are allowed to have
extrahepatic disease provided it is not judged likely to be life threatening within 3

- Patients must have a patent portal vein as documented by CT, MRI, or ultrasound

- Prior radiation therapy is allowed but must have been completed >= 4 weeks prior to
study entry; patients with history of prior radiation to the liver including
radio-labeled microspheres cannot take part in this study

- Eastern Cooperative Oncology Group performance status 0-1

- Previous surgery or RFA to the liver is allowed; patients with history of
chemoembolization or radio-labeled microspheres are excluded

- Life expectancy of >= 12 weeks

- Leukocytes >= 3,000/uL

- Absolute neutrophil count >= 1,500/uL

- Platelets >= 100,000/uL

- Total bilirubin =< ULN

- AST(SGOT)/ALT(SGPT)/Alkaline Phosphatase =< 2.5 X institutional ULN

- Creatinine < 2.0 mg/dL

- PT/PTT < 1.5 X ULN

- Women of childbearing potential (WOCBP) and sexually active males must agree to use
an accepted and effective method of contraception prior to study entry and for the
duration of the study; WOCBP include any female who has experienced menarche and who
has not undergone successful surgical sterilization (hysterectomy, bilateral tubal
ligation or bilateral oophorectomy) or is not postmenopausal; even women who are
using oral, implanted or injectable contraceptive hormones or mechanical products
such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides)
to prevent pregnancy or practicing abstinence or where partner is sterile (e.g.,
vasectomy) should be considered to be of child bearing potential

- Patients must demonstrate ability to understand and the willingness to sign a written
informed consent document


- Patients who have had chemotherapy (including targeted therapy i.e. cetuximab,
panitumumab) or radiotherapy =< 4 weeks or treatment with bevacizumab =< 6 weeks
prior to entering the study or those who have not recovered from acute adverse events
due to agents administered more than 4 weeks earlier, with the exclusion of alopecia
or neuropathy; patient with history of radiation to the liver including radio-labeled
microspheres at any point in their past will be excluded

- Patients may not be receiving nor have received any other investigational agent =< 4
weeks prior to study registration

- Pregnant or nursing women may not participate in this trial because of the increased
risk of fetal harm including death from the therapeutic agents

- Patients with known brain metastases are excluded from this study because of their
poor prognosis and frequent development of progressive neurological dysfunction that
would confound the evaluation of neurologic and other adverse events

- As patients with immune deficiency are at increased risk of lethal infections when
treated with marrow-suppressive therapy, known HIV-positive patients and those with
known hepatitis B or C are excluded from the study

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
bacterial infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements

- Patients with clinically evident ascites requiring medical management or
paracentesis, or Childs-Pugh score B/C are not eligible

- Patients with evidence of other cancer within 5 years, excluding adequately treated
basal cell carcinoma of the skin

- Patient with significant cardiac, renal or hematologic or pulmonary dysfunction

- Patients with previous chemoembolization to liver metastases

- Patients may not receive any other anticancer therapy while on study, including
immunotherapy; patients may not receive any other clinical investigational drug

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Time Frame:

Duration of time from start of treatment to progression

Safety Issue:


Principal Investigator

Efrat Dotan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center


United States: Food and Drug Administration

Study ID:

FCCC IRB 10-002



Start Date:

October 2010

Completion Date:

January 2012

Related Keywords:

  • Liver Metastases
  • Mucinous Adenocarcinoma of the Colon
  • Mucinous Adenocarcinoma of the Rectum
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Signet Ring Adenocarcinoma of the Colon
  • Signet Ring Adenocarcinoma of the Rectum
  • Stage IV Colon Cancer
  • Stage IV Rectal Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Cystadenocarcinoma
  • Neoplasm Metastasis
  • Liver Neoplasms



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111