Clinical trial NCT01648023: Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Unresectable Intrahepatic Cholangiocarcinoma
Keywords: LC Bead
Irinotecan
ONCOZENE BEAD
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Tumor Response (Overall Response = Complete Response + Partial Response + Progressive Disease + Stable Disease)
timeFrame: Assessed at 2, 4 and 6 months. 6 months reported.
Secondary outcomes:
measure: Overall Survival
timeFrame: 4.5 Years
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Robert Martin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: