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

• Status: Terminated
• Trial end date: 2017-01-12
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Concordia Laboratories Inc.
• Treatments: Cisplatin; Dihematoporphyrin Ether; Gemcitabine; Hematoporphyrin Derivative; Trioxsalen

Criteria

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