Back to resultsDrug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin (DELTIC)
Primary Purpose
Unresectable Intrahepatic Cholangiocarcinoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo
Gem-Cis or Gem-Carbo
Sponsored by
About this trial
This is an interventional treatment trial for Unresectable Intrahepatic Cholangiocarcinoma focused on measuring LC Bead, Irinotecan, ONCOZENE BEAD
Eligibility 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
Sites / Locations
- University of Louisville
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Randomization to LC OR ONCOZENE Bead with Gem-Cis or Gem-Carbo
Randomization to Gem-Cis or Gem-Carbo
Arm Description
Transarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo
Gem-Cis or Gem-Carbo alone
Outcomes
Primary Outcome Measures
Overall Survival
Long-term follow-up will occur every 3-4 months for up to one year after discontinuation of active study treatment. Subjects who have completed the long-term follow-up period will be monitored every 3 - 6 months until evidence of progression of disease. Once there is progression of disease subjects will be followed for overall survival by telephone or standard physician follow-ups as per standard of care until death.
Secondary Outcome Measures
Full Information
NCT ID
NCT01648023
First Posted
July 17, 2012
Last Updated
December 14, 2021
Sponsor
Robert C. Martin
Collaborators
University of Louisville
1. Study Identification
Unique Protocol Identification Number
NCT01648023
Brief Title
Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin
Acronym
DELTIC
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
September 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Robert C. Martin
Collaborators
University of Louisville
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Intrahepatic Cholangiocarcinoma
Keywords
LC Bead, Irinotecan, ONCOZENE BEAD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Randomization to LC OR ONCOZENE Bead with Gem-Cis or Gem-Carbo
Arm Type
Experimental
Arm Description
Transarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo
Arm Title
Randomization to Gem-Cis or Gem-Carbo
Arm Type
Active Comparator
Arm Description
Gem-Cis or Gem-Carbo alone
Intervention Type
Device
Intervention Name(s)
LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo
Intervention Type
Drug
Intervention Name(s)
Gem-Cis or Gem-Carbo
Primary Outcome Measure Information:
Title
Overall Survival
Description
Long-term follow-up will occur every 3-4 months for up to one year after discontinuation of active study treatment. Subjects who have completed the long-term follow-up period will be monitored every 3 - 6 months until evidence of progression of disease. Once there is progression of disease subjects will be followed for overall survival by telephone or standard physician follow-ups as per standard of care until death.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Martin, MD, PhD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin
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