- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02110953
Irinotecan-Eluting Beads in Treating Patients With Refractory Metastatic Colon or Rectal Cancer That Has Spread to the Liver
Phase I Study of Drug-Eluting Irinotecan Beads (DEBIRI) in Refractory Metastatic Colorectal Cancer With Liver-Only or Liver-Predominant Disease
Study Overview
Status
Conditions
- Mucinous Adenocarcinoma of the Rectum
- Signet Ring Adenocarcinoma of the Rectum
- Liver Metastases
- Mucinous Adenocarcinoma of the Colon
- Signet Ring Adenocarcinoma of the Colon
- Recurrent Colon Cancer
- Recurrent Rectal Cancer
- Stage IVA Colon Cancer
- Stage IVA Rectal Cancer
- Stage IVB Colon Cancer
- Stage IVB Rectal Cancer
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of drug eluting irinotecan (irinotecan hydrochloride) beads (irinotecan-eluting beads), delivered intrahepatically for the treatment of liver only or liver-predominantly colorectal metastatic disease.
SECONDARY OBJECTIVES:
I. To determine the response rate of colorectal liver metastases treated with drug-eluting irinotecan beads in refractory metastatic colorectal patients with liver only or liver predominant disease.
II. To determine the time to progression of colorectal liver metastases treated with drug-eluting irinotecan beads in refractory metastatic colorectal patients with liver only or liver predominant disease.
III. To determine the overall survival of patients treated with drug-eluting irinotecan beads for liver only or liver predominant metastatic disease from colorectal cancer.
OUTLINE: This is a dose-escalation study.
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.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for 2 years.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Creatinine =< 2.0 X mg/dL
- Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 X ULN
- Women of childbearing potential (WOCBP) and sexually active males must agree to use an accepted and effective method of contraception prior to study entry and for the duration of the study; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal; women who use oral, implanted or injectable contraceptive hormones, or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) should be considered to be of child bearing potential
- Patients must demonstrate ability to understand and the willingness to sign a written informed consent document
- Patients must discontinue any medication that causes strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) induction 2 weeks prior to treatment initiation; patients who are not able to discontinue these drugs are considered ineligible
- Patients must discontinue any medication that causes a strong CYP3A4 inhibition 1 week prior to treatment initiation; patients who are not able to discontinue these drugs are considered ineligible
Exclusion Criteria:
- Patients who have had chemotherapy (including targeted therapy i.e. cetuximab, panitumumab) or radiotherapy =< 4 weeks or treatment with bevacizumab =< 6 weeks prior to entering the study or those who have not recovered from acute adverse events due to agents administered more than 4 weeks earlier, with the exclusion of alopecia or neuropathy; patients with history of radiation to the liver including radio-labeled microspheres at any point in their past will be excluded
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (irinotecan-eluting beads)
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.
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Receive irinotecan hydrochloride-eluting beads via hepatic artery embolization
Receive irinotecan hydrochloride-eluting beads via hepatic artery embolization
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: 3 weeks
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3 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Response rate, classified using Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1
Time Frame: 8 weeks following administration of irinotecan-eluting beads
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8 weeks following administration of irinotecan-eluting beads
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Duration of overall response
Time Frame: 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
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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
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Time to progression
Time Frame: From start of treatment to progression in the treated lobe, assessed up to 2 years
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From start of treatment to progression in the treated lobe, assessed up to 2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Efrat Dotan, Fox Chase Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Neoplasms, Cystic, Mucinous, and Serous
- Recurrence
- Adenocarcinoma
- Rectal Neoplasms
- Cystadenocarcinoma
- Colonic Neoplasms
- Adenocarcinoma, Mucinous
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
Other Study ID Numbers
- GI-063 (Other Identifier: Fox Chase Cancer Center)
- P30CA006927 (U.S. NIH Grant/Contract)
- NCI-2014-00706 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mucinous Adenocarcinoma of the Rectum
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Mucinous Adenocarcinoma of the Colon | Signet Ring Adenocarcinoma of the Colon | Stage I Colon Cancer | Stage I Rectal Cancer
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John HaysSanofiUnknownMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Mucinous Adenocarcinoma of the Colon | Signet Ring Adenocarcinoma of the Colon | Stage IV Colon Cancer | Stage IV Rectal CancerUnited States
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National Cancer Institute (NCI)TerminatedMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Mucinous Adenocarcinoma of the Colon | Signet Ring Adenocarcinoma of the Colon | Stage IV Colon Cancer | Stage IV Rectal Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Adenocarcinoma of the Rectum | Adenocarcinoma...United States
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University of California, DavisNational Cancer Institute (NCI); Millennium Pharmaceuticals, Inc.CompletedUnspecified Adult Solid Tumor, Protocol Specific | Mucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Mucinous Adenocarcinoma of the Colon | Signet Ring Adenocarcinoma of the Colon | Stage IIIA Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal CancerUnited States
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National Cancer Institute (NCI)CompletedMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Stage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Adenocarcinoma of the RectumUnited States
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John HaysAmgenUnknownMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Mucinous Adenocarcinoma of the Colon | Signet Ring Adenocarcinoma of the Colon | Stage IV Colon Cancer | Stage IV Rectal Cancer | Recurrent Colon Cancer | Recurrent Rectal CancerUnited States
-
Abramson Cancer Center of the University of PennsylvaniaTerminatedMucinous Adenocarcinoma of the Rectum | Mucinous Adenocarcinoma of the ColonUnited States
-
Fox Chase Cancer CenterTerminatedMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Liver Metastases | Mucinous Adenocarcinoma of the Colon | Signet Ring Adenocarcinoma of the Colon | Stage IV Colon Cancer | Stage IV Rectal Cancer | Recurrent Colon Cancer | Recurrent Rectal CancerUnited States
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Fox Chase Cancer CenterNational Cancer Institute (NCI)TerminatedMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Mucinous Adenocarcinoma of the Colon | Signet Ring Adenocarcinoma of the Colon | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage... and other conditionsUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Mucinous Adenocarcinoma of the Colon | Signet Ring Adenocarcinoma of the Colon | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer | Stage IVB Colon Cancer | Stage IVB Rectal...United States
Clinical Trials on irinotecan-eluting beads
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Fudan UniversityNot yet recruitingColorectal Cancer | Liver MetastasesChina
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Federation Francophone de Cancerologie DigestiveActive, not recruiting
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Hans-Joachim Schmoll, MDBiocompatibles UK LtdTerminated
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Boston Scientific CorporationBiocompatibles UK LtdCompletedCarcinoma, Hepatocellular | Metastatic Colorectal CancerUnited Kingdom
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Ningbo Medical Center Lihuili HospitalRecruiting
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Fox Chase Cancer CenterTerminatedMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Liver Metastases | Mucinous Adenocarcinoma of the Colon | Signet Ring Adenocarcinoma of the Colon | Stage IV Colon Cancer | Stage IV Rectal Cancer | Recurrent Colon Cancer | Recurrent Rectal CancerUnited States
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National Institutes of Health Clinical Center (CC)TerminatedMelanoma | Colorectal Neoplasms | Neoplasm MetastasesUnited States
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The Central Hospital of Lishui CityNot yet recruitingCarcinoma | Small Cell Lung CancerChina
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King Faisal Specialist Hospital & Research CenterUnknownHepatocellular CarcinomaSaudi Arabia
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Tianjin Medical University Cancer Institute and...Not yet recruiting