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Trial record 1 of 1 for:    NCT01483027
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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

  Show 25 Study Locations
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
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 20, 2014