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

Completed · Not applicable

Conditions studied: Colorectal Cancer Metastatic

In brief

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.

Key facts

Study ID: NCT01483027
Run by: Boston Scientific Corporation
People needed: 428
Starts: 2012-01-01
Expected to finish: 2020-08-31
Last updated by the study team: 2022-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Must be male or female, 18 years of age or older, and of any ethnic or racial group
If primary tumor has not been resected, it must be clinically stable
Must have colorectal cancer with unresectable metastatic disease to the liver (unresectable unilobar or bilobar disease) who have disease progression in the liver with oxaliplatin or irinotecan based first line chemotherapy
Must be eligible to receive second-line standard-of-care chemotherapy with either 1) an oxaliplatin-based chemotherapy regimen, or 2) 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
Current Eastern Cooperative Oncology Group (ECOG) of 0-1 through screening to first treatment on study
Will have completed the first line chemotherapy regimen at least 14 days prior to initiation of 2nd line chemotherapy under the protocol
Patient is willing to participate in the study and has signed the study informed consent
Serum creatinine ≤ 2.0 mg/dL
Serum bilirubin up to 1.2 x upper limit of normal
Albumin ≥ 3.0 g/dL
Must have neutrophil count >1200/mm3 (1.2x109/L)

You may not qualify if…

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 (eg. closure device)
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 transcatheter arterial chemoembolization (TACE) or Y-90 microsphere therapy
Planned treatment with biological agents within 28 days prior to receiving TheraSphere
Planned liver directed therapy or radiation therapy
Intervention for, or compromise of, the Ampulla of Vater
Clinically evident ascites (trace ascites on imaging is acceptable)
Toxicities due to prior cancer therapy that have not resolved before the initiation of study treatment, if the Investigator determines that the continuing complication will compromise the 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 who are known to be human immunodeficiency virus (HIV) positive or have acute hepatitis B virus (HBV) or hepatitis C virus (HCV)
confirmed extra-hepatic metastases. Limited indeterminate extra-hepatic lesions 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 nodes with each individual nodes <1.5 cm)
Contraindications to the planned second line standard-of-care chemotherapy regimen
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization, and must not be breastfeeding and must agree to use contraceptive for duration of study.
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 judgment

Where it is running

University of California San Fransico, Moffitt Hospital — San Francisco, California, United States
University of Colorado Denver Anschutz Medical Campus — Aurora, Colorado, United States
Christiana Care Hospital — Newark, Delaware, United States
Lynn Clinical Research Center, Boca Raton Regional Hospital — Boca Raton, Florida, United States
University of Miami Miller School of Medicine, Florida — Miami, Florida, United States
Moffit Cancer Center — Tampa, Florida, United States
Northwestern University — Chicago, Illinois, United States
Rush University Medical Center — Chicago, Illinois, United States
Carle Clinic — Urbana, Illinois, United States
Indiana University School of Medicine — Indianapolis, Indiana, United States
University of Louisville — Louisville, Kentucky, United States
University of Michigan Health System — Ann Arbor, Michigan, United States
Wayne State Harper Hospita Karmanos Cancer Institute — Farmington Hills, Michigan, United States
Spectrum Health — Grand Rapids, Michigan, United States
Beaumont Hospital — Royal Oak, Michigan, United States
Allina Health, Virginia Piper Cancer Institute — Minneapolis, Minnesota, United States
Minneapolis — Minneapolis, Minnesota, United States
Mayo Clinic — Rochester, Minnesota, United States
Mallinckrodt Institute of Radiology — St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
University of Rochester — Rochester, New York, United States
Cleveland Clinic Foundation — Cleveland, Ohio, United States
The Ohio State University, Wexner Medical Center — Columbus, Ohio, United States
Miami Valley Hospital — Dayton, Ohio, United States
University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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