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



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:January 2012
End Date:September 2019

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A Phase III Clinical Trial Evaluating TheraSphere® in Patients With Metastatic Colorectal Carcinoma of the Liver Who Have Failed First Line Chemotherapy

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.


Inclusion Criteria

- 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 completed 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)

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 transcatheter arterial
chemoembolization (TACE) or Y-90 microsphere therapy

- Planned treatment with biological agents within 28 days prior to receiving TheraSphere
(may resume after Y-90 treatment or immediately if in control arm)

- 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
We found this trial at
39
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Ahmed Abdel Aal Kamel
Phone: 205-934-6504
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Marcus Noel, MD
Phone: 585-275-1599
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Guy Johnson, MD
Phone: 206-288-6358
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Kyle Cuneo
Phone: 734-764-6847
University of Michigan The University of Michigan was founded in 1817 as one of the...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Kyle Cuneo,, MD
Phone: 734-764-6847
University of Michigan Health System The University of Michigan is home to one of the...
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Aurora, Colorado 80045
Principal Investigator: Thor Johnson
Phone: 720-848-6618
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Thor Johnson
Phone: 720-848-6618
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Birmingham, Alabama 35294
Principal Investigator: Ahmed Abdel Aal Kamel
Phone: 205-934-6504
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Boca Raton, Florida 33486
Principal Investigator: George Khoriaty
Phone: 561-955-4539
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Marisa Hill, MD
Phone: 312-563-2169
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Mary Mulcahy, MD
Phone: 312-695-1518
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Ihab Haddadin
Phone: 216-445-9380
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Hooman Khabiri, MD
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: Patrick Sutphin, MD
Phone: 214-590-1310
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Dallas, Texas 75390
Principal Investigator: Patrick Sutphin
Phone: 214-645-2704
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Principal Investigator: Shannon Kauffman, MD
Phone: 937-208-3307
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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31995 Northwestern Highway
Farmington Hills, Michigan 48334
Principal Investigator: Phillip Phillip, MD
Phone: 313-576-9385
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Grand Rapids, Michigan 49503
Principal Investigator: Manish Varma, MD
Phone: 616-486-6111
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Houston, Texas 77030
Principal Investigator: Armeen Mahvash, MD
Phone: 713-792-5951
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Principal Investigator: Matthew S Johnson, MD
Phone: 317-963-0305
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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La Crosse, Wisconsin 54601
Principal Investigator: Azene Ezana, MD
Phone: 608-775-6782
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Robert Martin, MD, PhD
Phone: 502-629-3383
University of Louisville The University of Louisville is a state supported research university located in...
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Miami, Florida 33136
Principal Investigator: Lorraine Portelance, MD
Phone: 305-243-5491
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Milwaukee, Wisconsin 53226
Principal Investigator: William Rilling, MD
Phone: 414-805-2077
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Minneapolis, Minnesota 55407
Principal Investigator: Samith Kochuparambil, MD
Phone: 612-863-8551
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Minneapolis, Minnesota 55433
Principal Investigator: Samith Kochuparambil
Phone: 612-863-9466
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Constantinos Sofocleous
Phone: 646-888-1350
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Newark, Delaware 19718
Principal Investigator: Michael Guarino
Phone: 302-623-4453
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Norfolk, Virginia 23507
Principal Investigator: Harlan Vingan, MD
Phone: 757-388-5224
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Michael C Soulen, MD
Phone: 215-746-6788
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Royal Oak, Michigan 48073
Principal Investigator: Michael Savin
Phone: 248-551-7029
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Saint Louis, Missouri 63110
Principal Investigator: Darryl Zuckerman, MD
Phone: 314-747-1624
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Salt Lake City, Utah 84124
Principal Investigator: James Carlisle, MD
Phone: 801-268-7102
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505 Parnassus Avenue
San Francisco, California 94143
Principal Investigator: Nicholas Fidelman, MD
Phone: 415-353-2310
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Tampa, Florida 33612
Principal Investigator: Nishi Kothari, MD
Phone: 813-745-4090
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Trevose, Pennsylvania 19053
Principal Investigator: Aaron Shiloh, MD
Phone: 215-612-4881
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611 West Park Street
Urbana, Illinois 61801
Principal Investigator: Kendrith Rowland
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Vienna,
Principal Investigator: Loewe Christian, MD
Phone: 0043-1-40 400-58900
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1055 North Mayfair Road
Wauwatosa, Wisconsin 53226
Principal Investigator: Steven Huffman
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