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Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin (DELTIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by University of Louisville
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
Robert C. Martin, University of Louisville
ClinicalTrials.gov Identifier:
NCT01648023
First received: July 17, 2012
Last updated: April 18, 2017
Last verified: August 2016

July 17, 2012
April 18, 2017
July 2012
July 2020   (Final data collection date for primary outcome measure)
Tumor response according to modified RECIST Criteria [ Time Frame: 10 Weeks ]
Same as current
Complete list of historical versions of study NCT01648023 on ClinicalTrials.gov Archive Site
Hepatic Progression Free Survival [ Time Frame: Progression ]
Hepatic Progression Free Survival
Not Provided
Not Provided
 
Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin
Comparative, Prospective, Open-labeled, Randomized Phase II Study of Cisplatin or Carboplatin With Gemcitabine in Combination With Irinotecan-loaded Beads (LC or ONCOZENE) Versus Cisplatin or Carboplatin With Gemcitabine Alone in the Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
The purpose of this study is to find out if the combination of trans-arterial chemoembolization (LC or ONCOZENE BEAD) plus infusional chemotherapy is safe and more effective than just receiving the infusional chemotherapy alone.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Unresectable Intrahepatic Cholangiocarcinoma
  • Device: LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo
  • Drug: Gem-Cis or Gem-Carbo
  • Experimental: Randomization to LC OR ONCOZENE Bead with Gem-Cis or Gem-Carbo
    Transarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo
    Intervention: Device: LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo
  • Active Comparator: Randomization to Gem-Cis or Gem-Carbo
    Gem-Cis or Gem-Carbo alone
    Intervention: Drug: Gem-Cis or Gem-Carbo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
July 2020
July 2020   (Final data collection date for primary outcome measure)

Inclusion:

  • Patients over 18 years of age, of any race or sex, who have histologic and radiologic evidence of intrahepatic cholangiocarcinoma, who have been deemed unresectable by an experienced hepatic surgeon, and who are able to give informed consent, will be eligible
  • Patients with at least one measurable liver tumor, with size > 1cm (modified RECIST criteria)
  • Patients with liver-dominant disease defined as ≥80% tumor burden confined to the liver
  • Non-pregnant with an acceptable contraception in premenopausal women.
  • Hematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 75 x109/L, INR ≤1.3 (patients on therapeutic anticoagulants are not eligible if they can not stop there anti-coagulation prior to DEBIRI and meet INR criteria)
  • Adequate liver function as measured by: Total bilirubin ≤ 2.0 mg/dl,
  • Adequate renal function (creatinine ≤ 2.3 mg/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
  • Less than 70% of liver parenchymal tumor replacement

Exclusion:

  • Patient eligible for curative treatment (i.e. resection or tumor ablation).
  • Active bacterial, viral or fungal infection within 72 hours of study entry
  • Women who are pregnant or breast feeding
  • ECOG Performance Status score of >3
  • Life expectancy of < 3 months
  • 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 cell carcinoma of the skin.
  • Any contraindication for hepatic embolization procedures:
  • Large shunt as determined by the investigator (pretesting with TcMMA not required)
  • Severe atheromatosis vascular disease that precludes arterial cannulization
  • 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, gemcitabine, or cisplatin
  • Patients who have received prior systemic therapy with either irinotecan, gemcitabine, or cisplatin
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Mary Healey, CCRC 502-629-3327 mary.healey@louisville.edu
Contact: Robert Martin, MD, PhD 502-629-3355 robert.martin@louisville.edu
United States
 
 
NCT01648023
11-0181
Yes
Not Provided
Not Provided
Not Provided
Robert C. Martin, University of Louisville
Robert C. Martin
University of Louisville
Principal Investigator: Robert Martin, MD, PhD University of Louisville
University of Louisville
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP