Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)



Status:Terminated
Conditions:Liver Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/22/2017
Start Date:August 2014
End Date:March 2017

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Multicenter, Open-label, Randomized, Controlled Phase III Clinical Study of the Efficacy and Safety of Photodynamic Therapy Using Porfimer Sodium for Injection as Treatment for Unresectable Advanced Perihilar Cholangiocarcinoma

Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is
activated by a light from a laser that emits no heat. This technique works to allow the
medical doctor to specifically target and destroy abnormal or cancer cells while limiting
damage to surrounding healthy tissue. The activation of the drug is done by lighting the
abnormal areas using a fiber optic device (very fine fiber like a fishing line that permits
light transmission) inserted into a flexible tube with a light called cholangioscope for the
bile duct. The light will activate the porfimer sodium concentrated in the abnormal tissue,
leading to its destruction.

This research study will evaluate the efficacy and safety of PDT with porfimer sodium
administered with Standard Medical Care (SMC) compared to SMC alone on the overall survival
time of patients with non-operable advanced cholangiocarcinoma, a rare cancer of the bile
ducts. It will involve 200 patients across North America and Europe. Other countries may
participate if needed. Participation will last at least 18 months.


Inclusion Criteria:

- Males or females aged 18 or older

- Diagnosed with radiologically and biopsy or cytology confirmed inoperable perihilar
cholangiocarcinoma Bismuth Tumor Stage III/IV

- Non-menopausal or non-sterile female subjects of childbearing potential must have a
negative serum beta-HCG and use a medically acceptable form of birth control

- Able to sign an informed consent

Exclusion Criteria:

- Diagnostic of cholangiocarcinoma made more than 45 days prior to randomization

- Cholangiocarcinoma with extra-hepatic metastasis or concurrent non-solid malignancy

- Presence or history of other neoplasms (treated during the last five years prior to
study entry) other than carcinoma in situ of the cervix or basal carcinoma of the skin

- Previously received photodynamic therapy for cholangiocarcinoma

- Previously undergone surgical resection of the cholangiocarcinoma

- Previously undergone chemotherapy, brachytherapy, or radiotherapy prior to entering
the study

- Previously undergone metal stent insertion

- Porphyria or hypersensitivity to porphyrins (constituents of porfimer sodium),
gemcitabine, cisplatin or other platinum-containing compounds

- Presence of infection other than the infection of the bile duct (cholangitis)

- Acute or chronic medical or psychological illnesses that prevent endoscopy procedures

- Abnormal blood test results

- Severe impairment of your kidney or liver function

- Decompensated cirrhosis

- Pregnant or intend to become pregnant, breastfeeding or intend to breast-feed during
this study

- Participated in another drug study within 90 days before this one

- Unable or unwilling to complete the follow-up evaluations required for the study
We found this trial at
19
sites
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Raj J Shah, MD
Phone: 303-724-1862
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
Principal Investigator: Shivakumar Vignesh, MD
Phone: 718-270-1112
SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Andrew Bain, MD
Phone: 716-845-4427
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Sacramento, California 95814
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Dallas, Texas 75203
Principal Investigator: Paul R Tarnasky, MD
Phone: 214-947-1284
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Detroit, Michigan 48202
Principal Investigator: Cyrus Piraka, MD
Phone: 313-916-8422
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: M. Stanley Branch, MD
Phone: 919-681-2941
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Goodyear, Arizona 85338
Principal Investigator: Toufic Kachaamy, MD
Phone: 623-207-3955
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Kenner, Louisiana 70065
Principal Investigator: Virendra Joshi, MD
Phone: 504-842-4548
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Los Angeles, California 90033
Principal Investigator: Jacques Van Dam, MD, Ph.D.
Phone: 323-865-3075
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New York, New York 10021
Principal Investigator: Michel Kahaleh, MD
Phone: 646-962-4796
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: David Loren, MD
Phone: 215-955-8108
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Pittsburgh, Pennsylvania 15212
Principal Investigator: Abhijit Kulkarni, MD
Phone: 412-359-6990
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Scottsdale, Arizona 85259
Phone: 855-776-0015
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Seattle, Washington 98101
(888) 862-2737
Principal Investigator: Seng-Ian Gan, MD
Phone: 206-341-1295
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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101 W 8th Ave
Spokane, Washington 99204
(509) 474-3131
Principal Investigator: Wichit Srikureja, MD
Phone: 509-474-3823
Providence Sacred Heart Medical Center & Children's Hospital When Mother Joseph and the Sisters of...
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Toronto, Ontario
Principal Investigator: Paul Kortan, MD
Phone: 416-864-6060
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Tulsa, Oklahoma 74133
Principal Investigator: Leon Yoder, DO
Phone: 918-286-5448
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