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

Stopped early · Phase 3

Conditions studied: Hilar Cholangiocarcinoma

In brief

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.

Key facts

Study ID

NCT02082522

Run by

Concordia Laboratories Inc.

People needed

28

Starts

2014-11-12

Expected to finish

2017-01-12

Last updated by the study team

2019-08-28

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Western Regional Medical Center, Inc. — Goodyear, Arizona, United States
• Mayo Clinic Cancer Center — Scottsdale, Arizona, United States
• University of Southern California Keck School of Medicine — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Oschner Medical Center — Kenner, Louisiana, United States
• Henry Ford Health System — Detroit, Michigan, United States
• SUNY Downstate Medical Center — Brooklyn, New York, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Southwestern Regional Medical Center, Inc. — Tulsa, Oklahoma, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Allegheny Center for Digestive Health - AHN ASRI — Pittsburgh, Pennsylvania, United States
• Methodist Dallas Medical Center — Dallas, Texas, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Providence Sacred Heart Medical Center and Children's Hospital — Spokane, Washington, United States
• St. Michael's Hospital — Toronto, Ontario, Canada
• CHUM Hôpital St-Luc — Montreal, Quebec, Canada
• Klinikum Ludwigsburg — Ludwigsburg, Baden-Wurttemberg, Germany
• Klinikum Mannheim GmbH — Mannheim, Baden-Wurttemberg, Germany
• Johann-Wolfgang-Goethe Universität Frankfurt — Frankfurt am Main, Hesse, Germany
• Medizinische Hochschule Hannover — Hanover, Lower Saxony, Germany
• Universitätsklinikum Essen (AöR) — Essen, North Rhine-Westphalia, Germany

Full record on ClinicalTrials.gov

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