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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Louisville
Sponsor:
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT01648023
First received: July 17, 2012
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to find out if the combination of trans-arterial chemoembolization (LC BEAD) plus infusional chemotherapy is safe and more effective than just receiving the infusional chemotherapy alone.


Condition Intervention Phase
Unresectable Intrahepatic Cholangiocarcinoma
Device: LC Bead with Gem-Cis
Drug: Gemcitabine and Cisplatin
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: Comparative, Prospective, Open-labeled, Randomized Phase II Study of Cisplatin/Gemcitabine in Combination With Irinotecan-loaded LC Bead Versus Cisplatin/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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hepatic Progression Free Survival [ Time Frame: Progression ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Randomization to LC Bead with Gem-Cis
Transarterial Chemoembolization (LC Bead) with gemcitabine and cisplatin
Device: LC Bead with Gem-Cis
Active Comparator: Randomization to Gemcitabine and Cisplatin alone
Gemcitabine and cisplatin alone
Drug: Gemcitabine and Cisplatin

  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 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: Melissa Schlegel, CRC 502-629-3383 melissa.schlegel@louisville.edu
Contact: Charles Scoggins, MD, MBA 502-629-3355 charles.scoggins@louisville.edu

Locations
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Melissa Schlegel, CRC    502-629-3383    melissa.schlegel@louisville.edu   
Contact: Charles Scoggins, MD, MBA    502-629-3355    charles.scoggins@louisville.edu   
Principal Investigator: Charles Scoggins, MD, MBA         
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Charles Scoggins, MD, MBA University of Louisville
  More Information

No publications provided

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT01648023     History of Changes
Other Study ID Numbers: 11-0181
Study First Received: July 17, 2012
Last Updated: October 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Louisville:
LC Bead
Irinotecan

Additional relevant MeSH terms:
Cholangiocarcinoma
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Gemcitabine
Irinotecan
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing 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 August 28, 2014