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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
  Purpose
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.

Condition Intervention Phase
Unresectable Intrahepatic Cholangiocarcinoma
Device: LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo
Drug: Gem-Cis or Gem-Carbo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Tumor response according to modified RECIST Criteria [ Time Frame: 10 Weeks ]

Secondary Outcome Measures:
  • Hepatic Progression Free Survival [ Time Frame: Progression ]

Estimated Enrollment: 48
Study Start Date: July 2012
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Drug: Gem-Cis or Gem-Carbo

  Eligibility

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

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
  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: NCT01648023

Contacts
Contact: Mary Healey, CCRC 502-629-3327 mary.healey@louisville.edu
Contact: Robert Martin, MD, PhD 502-629-3355 robert.martin@louisville.edu

Locations
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Mary Healey, CCRC    502-629-3327    mary.healey@louisville.edu   
Contact: Robert Martin, MD, PhD    502-629-3355    robert.martin@louisville.edu   
Principal Investigator: Robert Martin, MD, PhD         
Sponsors and Collaborators
Robert C. Martin
University of Louisville
Investigators
Principal Investigator: Robert Martin, MD, PhD University of Louisville
  More Information

Responsible Party: Robert C. Martin, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT01648023     History of Changes
Other Study ID Numbers: 11-0181
Study First Received: July 17, 2012
Last Updated: April 18, 2017

Keywords provided by University of Louisville:
LC Bead
Irinotecan
ONCOZENE BEAD

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Irinotecan
Carboplatin
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on April 28, 2017