Trial record 3 of 42 for:    PDT with photofrin

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Concordia Laboratories Inc.
Sponsor:
Information provided by (Responsible Party):
Concordia Laboratories Inc.
ClinicalTrials.gov Identifier:
NCT02082522
First received: March 6, 2014
Last updated: June 5, 2016
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Hilar Cholangiocarcinoma
Drug: Photodynamic therapy-Photofrin
Procedure: Stenting procedure
Drug: Chemotherapy regimen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Concordia Laboratories Inc.:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Up to 4.5 years ] [ Designated as safety issue: No ]
    From the date of randomization until the date of death or the last date the subject was known to be alive


Secondary Outcome Measures:
  • Time-to-bilirubin response [ Time Frame: Up 30 days ] [ Designated as safety issue: No ]
    From the date of randomization until the date of first documented bilirubin response

  • Best overall tumor response [ Time Frame: Up to 4.5 years ] [ Designated as safety issue: No ]
    From the start of the treatment until disease progression or recurrence

  • Time-to-tumor progression [ Time Frame: Up to 4.5 years ] [ Designated as safety issue: No ]
    From the date of first documented response until the date that tumor progression was assessed

  • Change from baseline in performance status on the Karnofsky Performance Scale (KPS) [ Time Frame: Baseline, 7 days ] [ Designated as safety issue: No ]
    The KPS scores range from 0% to 100%

  • Change from baseline in performance status on the Karnofsky Performance Scale (KPS) [ Time Frame: Baseline, up to 4 weeks ] [ Designated as safety issue: No ]
    The KPS scores range from 0% to 100%

  • Change from baseline in performance status on the Karnofsky Performance Scale (KPS) [ Time Frame: Baseline, 13 weeks ] [ Designated as safety issue: No ]
    The KPS scores range from 0% to 100%

  • Change from baseline in performance status on the Karnofsky Performance Scale (KPS) [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
    The KPS scores range from 0% to 100%

  • Change from baseline in performance status on the Karnofsky Performance Scale (KPS) [ Time Frame: Baseline, 29 weeks ] [ Designated as safety issue: No ]
    The KPS scores range from 0% to 100%

  • Change from baseline in performance status on the Karnofsky Performance Scale (KPS) [ Time Frame: Baseline, 41 weeks ] [ Designated as safety issue: No ]
    The KPS scores range from 0% to 100%

  • Change from baseline in performance status on the Karnofsky Performance Scale (KPS) [ Time Frame: Baseline, 54 weeks ] [ Designated as safety issue: No ]
    The KPS scores range from 0% to 100%

  • Change from baseline in performance status on the Karnofsky Performance Scale (KPS) [ Time Frame: Baseline, 66 weeks ] [ Designated as safety issue: No ]
    The KPS scores range from 0% to 100%

  • Change from baseline in performance status on the Karnofsky Performance Scale (KPS) [ Time Frame: Baseline, 78 weeks ] [ Designated as safety issue: No ]
    The KPS scores range from 0% to 100%

  • Change from baseline in health-related quality of life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) [ Time Frame: Baseline, 7 days ] [ Designated as safety issue: No ]
    Final scores for multi-item scales and single-item measures will range from 0 to 100

  • Change from baseline in health-related quality of life on the 4- and 7-point EORTC QLQ-C30 [ Time Frame: Baseline, up to 4 weeks ] [ Designated as safety issue: No ]
    Final scores for multi-item scales and single-item measures will range from 0 to 100

  • Change from baseline in health-related quality of life on the 4- and 7-point EORTC QLQ-C30 [ Time Frame: Baseline, 13 weeks ] [ Designated as safety issue: No ]
    Final scores for multi-item scales and single-item measures will range from 0 to 100

  • Change from baseline in health-related quality of life on the 4- and 7-point EORTC QLQ-C30 [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
    Final scores for multi-item scales and single-item measures will range from 0 to 100

  • Change from baseline in health-related quality of life on the 4- and 7-point EORTC QLQ-C30 [ Time Frame: Baseline, 29 weeks ] [ Designated as safety issue: No ]
    Final scores for multi-item scales and single-item measures will range from 0 to 100

  • Change from baseline in health-related quality of life on the 4- and 7-point EORTC QLQ-C30 [ Time Frame: Baseline, 41 weeks ] [ Designated as safety issue: No ]
    Final scores for multi-item scales and single-item measures will range from 0 to 100

  • Change from baseline in health-related quality of life on the 4- and 7-point EORTC QLQ-C30 [ Time Frame: Baseline, 54 weeks ] [ Designated as safety issue: No ]
    Final scores for multi-item scales and single-item measures will range from 0 to 100

  • Change from baseline in health-related quality of life on the 4- and 7-point EORTC QLQ-C30 [ Time Frame: Baseline, 66 weeks ] [ Designated as safety issue: No ]
    Final scores for multi-item scales and single-item measures will range from 0 to 100

  • Change from baseline in health-related quality of life on the 4- and 7-point EORTC QLQ-C30 [ Time Frame: Baseline, 78 weeks ] [ Designated as safety issue: No ]
    Final scores for multi-item scales and single-item measures will range from 0 to 100


Estimated Enrollment: 200
Study Start Date: August 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Photodynamic therapy-Photofrin plus SMC
Photodynamic therapy (PDT) involves the i.v. injection of Photofrin followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) will be applied to the tumor. A second light application will be given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients will undergo stenting as part of standard medical care procedure. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) may be given at 3-month intervals. Standard Medical Care (SMC) is defined as stenting procedure plus chemotherapy regimen.
Drug: Photodynamic therapy-Photofrin
Photodynamic therapy (PDT) involves the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device during an endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC). Two days after the injection, a laser light (180 J/cm(2)) will be applied to the tumor. A second light application will be given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients will undergo stenting as part of standard medical care procedure. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) may be given at 3-month intervals.
Other Name: PDT-Photofrin
Procedure: Stenting procedure
As per standard medical procedures, stenting procedure consists in the placement of stents above the main tumors of the right and left hepatic bile ducts via endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) when the ERCP approach has been unsuccessful.
Other Name: Stents placement
Drug: Chemotherapy regimen
The regimen will comprise gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen may be administered if there is no disease progression or intolerable toxicity.
Other Name: Gemcitabine/Cisplatin
Active Comparator: Standard Medical Care (SMC)
Standard Medical Care (SMC) is defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen will comprise gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen may be administered if there is no disease progression or intolerable toxicity.
Procedure: Stenting procedure
As per standard medical procedures, stenting procedure consists in the placement of stents above the main tumors of the right and left hepatic bile ducts via endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) when the ERCP approach has been unsuccessful.
Other Name: Stents placement
Drug: Chemotherapy regimen
The regimen will comprise gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen may be administered if there is no disease progression or intolerable toxicity.
Other Name: Gemcitabine/Cisplatin

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02082522

Contacts
Contact: Michelle Depot, Ph.D. 514-971-9855 mdepot@concordiarx.com

  Show 30 Study Locations
Sponsors and Collaborators
Concordia Laboratories Inc.
Investigators
Principal Investigator: Michel Kahaleh, MD Weill Medical College of Cornell University
  More Information

Responsible Party: Concordia Laboratories Inc.
ClinicalTrials.gov Identifier: NCT02082522     History of Changes
Other Study ID Numbers: PIN-PHO1201 
Study First Received: March 6, 2014
Last Updated: June 5, 2016
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic
Canada: Health Canada
South Korea: Ministry of Food and Drug Safety
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Concordia Laboratories Inc.:
Photodynamic therapy
Porfimer sodium
Photofrin
PDT
Cholangiocarcinoma
Unresectable perihilar cholangiocarcinoma
Klatskin tumor
Gemcitabine
Cisplatin
Stents
CCA
Bile duct cancer
Bile duct tumor
Bile duct adenocarcinoma
Chemotherapy

Additional relevant MeSH terms:
Dihematoporphyrin Ether
Hematoporphyrin Derivative
Trioxsalen
Cholangiocarcinoma
Klatskin Tumor
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents
Photosensitizing Agents

ClinicalTrials.gov processed this record on August 25, 2016