Phase 2
N=14
Irinotecan -Eluting LC Bead-M1 (DEBIRI-M1) for Patients With Liver Metastases From Colorectal Cancer
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02015754 ↗Enrolled (actual)
14
Serious AEs
7.1%
Results posted
Mar 2018
Primary outcome: Primary: Success of DEBIRI-M1 Procedure as a Measure of Feasibility (Percentage of Successful Treatments) — 100 percentage of successful treatments
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DEBIRI (Drug); LC Bead M1 (Device); TACE (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success of DEBIRI-M1 Procedure as a Measure of Feasibility (Percentage of Successful Treatments) |
100 | — |
| PRIMARY Safety, Defined as Demonstrating Tolerable Device-related Toxicity Profile in the Use of DEBIRI Beads Used to Treat Hepatic Metastases in Patients With Colorectal Cancer |
2; 1; 3; 2; 1; 1 | — |
| SECONDARY Efficacy - Tumor Response by RECIST |
0; 1; 8; 4; 1; 9 | — |
| SECONDARY Efficacy - Tumor Response by mRECIST |
0; 0; 9; 4; 0; 9 | — |
| SECONDARY Efficacy -Tumor Response by European Association for the Study of the Liver (EASL) Criteria |
0; 3; 4; 6; 3; 7 | — |
| SECONDARY Efficacy - Tumor Response by World Health Organization (WHO) Criteria |
0; 1; 9; 3; 1; 10 | — |
| SECONDARY Number of Participants With Change in Carcinoembryonic Antigen (CEA) |
6 | 0.004 sig |
| SECONDARY Median Overall Survival |
18.7 | — |
| SECONDARY One-year Survival Percentage |
36 | — |
Summary
Purpose:
The purpose of this study is to determine the feasibility and safety of using small beads (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat patients with liver lesions from colorectal cancer. The beads (LC-Bead M1) will be loaded with irinotecan (DEBIRI-M1), and used to administer transarterial chemoembolization (TACE).
Eligibility:
Patients with liver cancer from colorectal cancer.
Study Overview/ Treatment:
DEBIRI, loaded with irinotecan, is a device that utilizes tiny beads (70-150 microns) to deliver chemotherapy agents into liver tumor(s) via the hepatic artery. This device allows for continuous release of irinotecan into the liver tumor tissue(s) causing necrosis of the targeted tumor(s). The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. Response to therapy will be evaluated monthly by clinic visits and blood tests (to include assessment of liver function and tumor markers) and by imaging (usually MRIs) every 1-2 months. Patients will be on study for 6 months after which they will be exited from the study and followed for survival. Once exited from the study they will continue to be eligible to receive DEBIRI, should it be recommended.
Eligibility Criteria
Inclusion Criteria
-Patients with a diagnosis of colorectal cancer with hepatic metastases who have failed or are intolerant to at least one systemic chemotherapy or liver directed therapy.
- The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at study entry.
- The patient is age 18 years or older.
- The patient has a life expectancy of >12 weeks.
- Patients with liver dominant disease defined as >/=75% tumor body burden confined to the liver
- Less than 60% liver tumor replacement
- At least one month has elapsed since most recent prior cancer therapy with the following exception:
-Chemotherapy (excluding irinotecan based regimens) may continue if there is evidence of hepatic progression on treatment providing there is no change in the therapy in the 1 month prior to DEBIRI-TACE treatment and any immediate chemotherapeutic toxicity that will complicate DEBIRI-TACE is resolved. In this case, the chemotherapy may continue because it is continuing to control the extrahepatic disease.
- The patient has measurable disease that will be directly treated with intrahepatic therapy (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).
- Patients with at least one measurable liver metastases> 2 cm.
- Patients with patent main portal vein
- The patient has adequate hematologic function as defined by the following criteria:
-An absolute neutrophil count (ANC) >/= 1500/mL, Hemoglobin >/= 9.5 g/dL, and a Platelet count >/=75,000/mL, INR 2.
- The patient has adequate renal function, as defined by the following criteria:
-Serum creatinine 150 mmHg, diastolic blood pressure>90 mmHg, found on 2 consecutive measurements separated by a 1-week period despite adequate medical support)
- Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment [NCI-CTCAE Grade 3] or asymptomatic sustained ventricular tachycardia)
- The patient is pregnant or breast-feeding.
- Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements
- There is evidence of substance abuse or medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results
- The patient is allergic to contrast media that cannot be readily prevented with premedication or managed.
- 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
- The patient has peritoneal disease or ascites (greater than trace on imaging).
Data sourced from ClinicalTrials.gov (NCT02015754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.