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

NCT01648023 | Completed Phase 2 Results DMC FDA Drug FDA Device

• 1 other identifier: 11-0181
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Unresectable Intrahepatic Cholangiocarcinoma

Keywords

LC Bead; Irinotecan; ONCOZENE BEAD

Outcome Measures

Primary Outcomes (1)

• Tumor Response (Overall Response = Complete Response + Partial Response + Progressive Disease + Stable Disease)

  Tumor response will be determined using Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Response will be classified as: Complete Response - disappearance of all lesions; Partial Response - at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter or 30% reduction in arterial enhancement; Progressive Disease - at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest longest diameter recorded since start of treatment or appearance of one or more new lesions greater than 1cm in size; Stable Disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since start of treatment.

  Assessed at 2, 4 and 6 months. 6 months reported.

Secondary Outcomes (1)

• Overall Survival

  4.5 Years

Study Arms (2)

Randomization to LC OR ONCOZENE Bead with Gem-Cis or Gem-Carbo

EXPERIMENTAL

Transarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo

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

Randomization to Gem-Cis or Gem-Carbo

ACTIVE COMPARATOR

Gem-Cis or Gem-Carbo alone

Drug: Gem-Cis or Gem-Carbo

Interventions

LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo DEVICE

Randomization to LC OR ONCOZENE Bead with Gem-Cis or Gem-Carbo

Gem-Cis or Gem-Carbo DRUG

Randomization to Gem-Cis or Gem-Carbo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Robert C. Martin: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Results Point of Contact

• Title: Robert Martin, MD, PhD
• Organization: University of Louisville

robert.martin@louisville.edu

502-629-3355

Study Officials

• Robert Martin, MD, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 24, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2019
• Study Completion: September 1, 2019
• Last Updated: February 27, 2025
• Results First Posted: January 13, 2022

Record last verified: 2021-12

Locations

US (1)