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

Unresectable Intrahepatic Cholangiocarcinoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648023
• Other study ID #: 11-0181
• Status: Completed
• Phase: Phase 2
• Start date: July 2012
• Est. completion date: September 2019

Study information

• Verified date: December 2021
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ßHCG 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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Unresectable Intrahepatic Cholangiocarcinoma

Intervention

Device:
• LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo

Drug:
• Gem-Cis or Gem-Carbo

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Robert C. Martin	University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years