Efficacy Evaluation of TheraSphere Following Failed First Line Chemotherapy in Metastatic Colorectal Cancer (EPOCH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by BTG International Inc.
Sponsor:
Collaborator:
Biocompatibles UK Ltd
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT01483027
First received: November 24, 2011
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

The effectiveness and safety of TheraSphere will be evaluated in patients with colorectal cancer with metastases in the liver, who are scheduled to receive second line chemotherapy. All patients receive the standard of care chemotherapy with or without the addition of TheraSphere.


Condition Intervention Phase
Colorectal Cancer Metastatic
Device: TheraSphere
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Clinical Trial Evaluating TheraSphere® in Patients With Metastatic Colorectal Carcinoma of the Liver Who Have Failed First Line Chemotherapy

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: January 2012
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group
Standard of care second-line chemotherapy plus TheraSphere
Device: TheraSphere
yttrium 90 microspheres
No Intervention: Control group
Standard of care second-line chemotherapy with no added therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, 18 years of age, any ethnic or racial group
  • Unresectable primary tumor must be stable or asymptomatic
  • Patients with unresectable metastatic disease to the liver (unresectable unilobar or bilobar disease) who have disease progression with oxaliplatin or irinotecan based first line chemotherapy
  • Eligible to receive second-line standard-of-care chemotherapy with either an oxaliplatin-based or an irinotecan-based chemotherapy regimen
  • Must have baseline efficacy images with measurable target tumors in the liver according to RECIST 1.1 using standard imaging techniques taken within 28 days prior to randomization. Images must be taken after or at the time of completion of first-line chemotherapy
  • Tumor replacement ≤ 50% of total liver volume
  • ECOG of 0-1 through screening to first treatment
  • First line chemotherapy regimen completed at least 14 days prior to initiation of 2nd line chemotherapy under the protocol
  • Patient willing to participate and has signed informed consent
  • Serum creatinine ≤2.0 mg/dL
  • Serum bilirubin 1.2 x upper limit of normal
  • Albumin ≥ 2.0 g/dL
  • Neutrophil count >1200/mm³ (1.2x10⁹/L)

Exclusion Criteria:

  • History of hepatic encephalopathy
  • Contraindications to angiography and selective visceral catheterization such as bleeding diathesis or coagulopathy that is not correctable by usual therapy of hemostatic agents
  • History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
  • Presentation of pulmonary insufficiency or clinically evident chronic obstructive pulmonary disease
  • Cirrhosis or portal hypertension
  • Prior external beam radiation treatment to the liver
  • Prior intra-arterial liver directed therapy, including TACE or Y-90 microsphere therapy
  • VEGF inhibitors within 28 days prior to receiving TheraSphere (may resume after Y-90 treatment or immediately if in control arm)
  • Clinically evident ascites (trace ascites on imaging is acceptable)
  • Planned liver-directed therapy or radiation therapy
  • Intervention for, or compromise of, the Ampulla of Vater
  • Toxicities due to prior cancer therapy that have not resolved before initiation of study treatment, if the investigator determines that the continuing complication will compromise safe treatment of the patient
  • Significant life-threatening extra-hepatic disease, including patients who are on dialysis, have unresolved diarrhea, have serious unresolved infections, including patients known to be HIV positive or have acute HBV or HCV
  • Must not have any significant extra-hepatic metastases. Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (up to 5 lesions in the lung, with each individual lesion <1 cm; any number of lymph lesions with each individual lesion <1.5 cm)
  • Contraindications to planned second line standard-of-care chemotherapy
  • Women of child-bearing potential must have negative serum pregnancy test within 14 days prior to randomization and must not be breast feeding
  • Participation in a clinical trial with an investigational therapy within 30 days prior to randomization
  • Co-morbid disease or condition that would place the patient at undue risk and preclude safe use of TheraSphere treatment, in the investigator's judgement
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483027

Contacts
Contact: Medha Kelkar, MPharm, PMP 905 403 9901 ext 2667 medha.kelkar@theoremclinical.com

  Hide Study Locations
Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Curt Johanson    415-353-2310    curt.johanson@cc.ucsf.edu   
Principal Investigator: Nicholas Fidelman, MD         
United States, District of Columbia
George Washington University Hospital Recruiting
Washington, District of Columbia, United States, 20037
Contact: Cathy Garey    202-741-3168    cgarey@mfa.gwu.edu   
Principal Investigator: Shawn Sarin, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Carlene del Castillo    312-695-1518    carlene.castillo@northwestern.edu   
Principal Investigator: Mary Mulcahy, MD         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Asley Roche    312-563-2169    ashley_roche@rush.edu   
Principal Investigator: Marisa Hill, MD         
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Tamiko MaGee    317-278-7557    trmagee@iupui.edu   
Principal Investigator: Matthew S Johnson, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Melissa Schlegel    502-629-3383    melissa.schlegel@louisville.edu   
Principal Investigator: Robert Martin, MD, PhD         
United States, Maryland
The Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Diane Reyes    410-614-4212    dreyes@jhmi.edu   
Principal Investigator: Jeff Geschwind, MD         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Colette Zack    313-576-9385    zackc@karmanos.org   
Principal Investigator: Minsig Choi, MD         
Spectrum Health / Advanced Radiology Services Recruiting
Grand Rapids, Michigan, United States, 49506
Contact: Kimberly Mohr, BSN,RN,CCRC    616-486-6111    kimberly.mohr@spectrumhealth.org   
Principal Investigator: Manish Varma, MD         
Saint Mary's Healthcare Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Kathy Estkowski    616-685-5156    estkowk@mercyhealth.com   
Principal Investigator: Matthew A Tiede, MD         
United States, Minnesota
Virginia Piper Cancer Institute, Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Lisa Albers    612-863-9466    lisa.albers@allina.com   
Principal Investigator: Joseph Leach, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jennifer Pickett    507-284-0586    pickett.jennifer@mayo.edu   
Principal Investigator: Steven Alberts, MD         
United States, Missouri
Washington University Recruiting
St Louis, Missouri, United States, 63110
Contact: Robin Haverman    314-747-1624    havermanr@wustl.edu   
Principal Investigator: Darryl Zuckerman, MD         
United States, New York
Mt Sinai Medical School, Tisch Cancer Institute Recruiting
New York, New York, United States, 10029-6574
Contact: Rothschild Soto    212-824-7379    rothschild.soto@mssm.edu   
Principal Investigator: Randall Holcombe, MD         
United States, Oregon
Legacy Meridian Park Medical Center Recruiting
Tualatin, Oregon, United States, 97062
Contact: Susan    503-413-8330    sstaat@lhs.org   
Principal Investigator: Jason Bauer, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Evelyn Stainthorpe, BS, CCRC    212-662-6983    evelyn.stainthorpe@uphs.upenn.edu   
Principal Investigator: Michael C Soulen, MD         
Diagnostic Imaging Inc Recruiting
Trevose, Pennsylvania, United States, 19053
Contact: Sally Wagenborg, RN, CCRP    215-612-4881    swagenborg@ariahealth.org   
Principal Investigator: Aaron Shiloh, MD         
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Cynthia Brown    713-792-2924    cbrown@mdanderson.org   
Principal Investigator: Armeen Mahvash, MD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Royanne Koogler    434-924-9496    RLB8Y@virginia.edu   
Contact: Snjezana Zaja-Milatovic    434-243-6575    SZ7S@virginia.edu   
Principal Investigator: Geoffrey Weiss, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Stephanie DiGiacomo    206-288-6358    sdigiaco@seattlecca.org   
Principal Investigator: Siddharth Padia, MD         
Principal Investigator: William P Harris, MD         
United States, Wisconsin
University of Wisconsin Hospital & Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Carissa Amundson    608-265-1181    camund@uwcarbone.wisc.edu   
Contact: Kathryn Sklenar    608-263-9912    ksklenar@uwcarbone.wisc.edu   
Principal Investigator: William Schelman, MD, PhD         
Medical College of Wisconsin, Inc. Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Elizabeth Weil    414-805-3028    eweil@mcw.edu   
Principal Investigator: William Rilling, MD         
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Cheryl Geen-Smith    (416) 946-4501 ext 6639    cheryl.geen-smith@uhn.ca   
Principal Investigator: Jeff Jaskolka, MD         
Canada, Quebec
McGill University Health Centre / Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Ayat Salman    (514) 934-1934 ext 36237    Ayat.Salman@MUHC.MCGILL.CA   
Principal Investigator: Tatiana Cabrera, MD         
France
Centre Eugene Marquis Recruiting
Rennes, France, 35042 cedex
Principal Investigator: Eveline Boucher, MD         
Sponsors and Collaborators
BTG International Inc.
Biocompatibles UK Ltd
Investigators
Principal Investigator: Mary Mulcahy, MD Northwestern University
  More Information

No publications provided

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01483027     History of Changes
Other Study ID Numbers: TS-102
Study First Received: November 24, 2011
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014