Irinotecan-Eluting Beads in Treating Patients With Refractory Metastatic Colon or Rectal Cancer That Has Spread to the Liver

NCT02110953 | Terminated Phase 1 DMC

• 3 other identifiers: GI-063NCI-2014-00706P30CA006927
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects and best dose of irinotecan-eluting beads in treating patients with colon or rectal cancer that has spread to the liver and does not respond to treatment with standard therapy. Irinotecan-eluting beads are tiny beads that have been loaded with irinotecan hydrochloride, a chemotherapy drug. Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. This treatment delivers the chemotherapy directly to the tumor area inside the liver instead of to the whole body as with systemic delivery of the drug. Irinotecan-eluting beads may work better that standard chemotherapy in treating patients with colon or rectal cancer that has spread to the liver.

Conditions

Liver Metastases; Mucinous Adenocarcinoma of the Colon; Mucinous Adenocarcinoma of the Rectum; Recurrent Colon Cancer; Recurrent Rectal Cancer; Signet Ring Adenocarcinoma of the Colon; Signet Ring Adenocarcinoma of the Rectum; Stage IVA Colon Cancer; Stage IVA Rectal Cancer; Stage IVB Colon Cancer; Stage IVB Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of irinotecan-eluting beads, determined by dose limiting toxicities, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

  3 weeks

Secondary Outcomes (3)

• Response rate, classified using Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1

  8 weeks following administration of irinotecan-eluting beads

• Duration of overall response

  From the time measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years

• Time to progression

  From start of treatment to progression in the treated lobe, assessed up to 2 years

Study Arms (1)

Treatment (irinotecan-eluting beads)

EXPERIMENTAL

Patients receive irinotecan-eluting beads via hepatic artery embolization every 3 weeks for a total of 2 treatments in the absence of disease progression or unacceptable toxicity. Patients with bi-lobular disease and no evidence of progression in the treated lobe may repeat treatment at the discretion of the treating physician.

Combination Product: irinotecan-eluting beads; Procedure: hepatic artery embolization

Interventions

irinotecan-eluting beads COMBINATION_PRODUCT

Receive irinotecan hydrochloride-eluting beads via hepatic artery embolization

Treatment (irinotecan-eluting beads)

hepatic artery embolization PROCEDURE

Receive irinotecan hydrochloride-eluting beads via hepatic artery embolization

Treatment (irinotecan-eluting beads)

Eligibility Criteria

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

You may qualify if:

• Patients must have a histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic to the liver and unresectable and for which standard curative measures do not exist or are no longer effective
• Patients must have received prior fluoropyrimidine, oxaliplatin and irinotecan-based therapy for their disease and had progression or intolerance to these agents that resulted in treatment discontinuation
• Liver disease must not be amenable to potentially curative surgical resection
• Patients must have liver-only or liver-predominant disease to be eligible for this study; liver predominant disease is defined dominant metastatic burden in the liver, with extra-hepatic disease that is judged by the investigator as unlikely to be life threatening within 3 months
• Patients must have a patent portal vein as documented by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound
• Prior radiation therapy is allowed but must have been completed \>= 4 weeks prior to study entry; patients with history of prior radiation to the liver including radio-labeled microspheres cannot take part in this study
• Eastern Cooperative Oncology Group performance status 0 or 1
• Previous surgery or radiofrequency ablation (RFA) to the liver is allowed; patients with history of chemoembolization or radio-labeled microspheres are excluded
• Life expectancy of \>= 12 weeks
• Leukocytes \>= 3,000/μL
• Absolute neutrophil count \>= 1,500/μL
• Platelets \>= 100,000/μL
• Total bilirubin =\< 1.5 X upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2 X ULN
• Alkaline phosphatase =\< 2 X ULN

You may not qualify if:

• Patients may not be receiving nor have received any other investigational agent =\< 4 weeks prior to study registration
• Pregnant or nursing women may not participate in this trial
• Patients with known brain metastases are excluded from this study
• Known human immunodeficiency virus (HIV)-positive patients and those with known hepatitis B or C are excluded from the study
• Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active bacterial infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients with clinically evident ascites requiring medical management or paracentesis, or Childs-Pugh score B/C are not eligible
• Patients with evidence of other cancer within 5 years, excluding adequately treated basal cell carcinoma of the skin
• Patient with significant cardiac, renal or hematologic or pulmonary dysfunction
• Patients with previous chemoembolization to liver metastases

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Efrat Dotan

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: January 29, 2016
• Primary Completion: April 4, 2017
• Study Completion: August 16, 2017
• Last Updated: February 26, 2018

Record last verified: 2017-04

Locations

US (1)