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

This study is currently recruiting participants.
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

July 17, 2012
October 17, 2013
July 2012
July 2014   (final data collection date for primary outcome measure)
Tumor response according to modified RECIST Criteria [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01648023 on ClinicalTrials.gov Archive Site
Hepatic Progression Free Survival [ Time Frame: Progression ] [ Designated as safety issue: No ]
Hepatic Progression Free Survival [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Unresectable Intrahepatic Cholangiocarcinoma
  • Device: LC Bead with Gem-Cis
  • Drug: Gemcitabine and Cisplatin
  • Experimental: Randomization to LC Bead with Gem-Cis
    Transarterial Chemoembolization (LC Bead) with gemcitabine and cisplatin
    Intervention: Device: LC Bead with Gem-Cis
  • Active Comparator: Randomization to Gemcitabine and Cisplatin alone
    Gemcitabine and cisplatin alone
    Intervention: Drug: Gemcitabine and Cisplatin
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 2015
July 2014   (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
Both
18 Years and older
No
Contact: Melissa Schlegel, CRC 502-629-3383 melissa.schlegel@louisville.edu
Contact: Charles Scoggins, MD, MBA 502-629-3355 charles.scoggins@louisville.edu
United States
 
NCT01648023
11-0181
Yes
University of Louisville
University of Louisville
Not Provided
Principal Investigator: Charles Scoggins, MD, MBA University of Louisville
University of Louisville
October 2013

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