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Biliary Stenting With or Without Photodynamic Therapy in Treating Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors That Cannot Be Removed by Surgery
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2008
Sponsored by: University College London Hospitals
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00513539
  Purpose

RATIONALE: Biliary stenting is the placement of a tube in the bile ducts to keep a blocked area open. Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. It is not yet known whether biliary stenting is more effective with or without photodynamic therapy in treating patients with biliary tract tumors.

PURPOSE: This randomized phase III trial is studying biliary stenting to see how well it works compared with biliary stenting and photodynamic therapy using porfimer sodium in treating patients with locally advanced, recurrent, or metastatic cholangiocarcinoma or other biliary tract tumors that cannot be removed by surgery.


Condition Intervention Phase
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Drug: porfimer sodium
Procedure: biliary stenting
Phase III

MedlinePlus related topics: Cancer Dietary Sodium Gallbladder Cancer
Drug Information available for: Porfimer sodium Dihematoporphyrin ether Trioxsalen
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: Porfimer Sodium Photodynamic Therapy Plus Stenting Versus Stenting Alone in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumours: a Multicentre, Randomised, Phase Lll Study

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival every 3 months [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTC v. 3.0 [ Designated as safety issue: Yes ]
  • Quality of life as assessed by EORTC QLQ 30 and PAN 26 at baseline and 1, 3, and 6 months after completion of study treatment [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: July 2007
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To assess the efficacy, in terms of overall survival, of biliary stenting with vs without photodynamic therapy using porfimer sodium in advanced, recurrent, or metastatic biliary tract carcinoma.

Secondary

  • To evaluate the two treatments arms with respect to progression-free survival, toxicity using NCI Common Toxicity Criteria (version 3.0), and quality of life.

OUTLINE: This is a multicenter study. Patients are stratified by participating center, primary site (gallbladder vs bile duct), disease stage (locally advanced vs metastatic), prior therapy (i.e., surgery, radiotherapy or chemotherapy) (yes vs no), performance score (0 vs 1 vs 2 vs 3), and prior treatment arm on UK chemotherapy trial ABC-02 (gemcitabine hydrochloride alone vs gemcitabine hydrochloride and cisplatin). Patients are randomized to 1 of 2 arms.

  • Arm I: Patients undergo either endoscopic or percutaneous drainage and insertion of unilateral or bilateral plastic endoprostheses above the main strictures of the right and left hepatic bile ducts.
  • Arm II: Patients undergo treatment as in arm I. Patients also receive porfimer sodium IV and then undergo laser activation 48 hours later.

After completion of study treatment, patients are followed every 3 months for at least 3 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Histopathological/cytological diagnosis of nonresectable locally advanced, recurrent, or metastatic biliary tract carcinoma (intra- or extra-hepatic), or gallbladder carcinoma
  • Adequate biliary drainage, with no evidence of active uncontrolled infection (patients on antibiotics are eligible)

Exclusion criteria:

  • Porphyria
  • No brain metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status 0, 1, 2, or 3
  • Estimated life expectancy > 3 months
  • Women of child-bearing potential should have a negative pregnancy test prior to study entry AND be using an adequate contraception method, which must be continued for 1 month after completion of treatment
  • Not pregnant or nursing

Exclusion criteria:

  • History of prior malignancy that will interfere with the response evaluation (exceptions include in-situ carcinoma of the cervix treated by cone-biopsy/resection, non-metastatic basal and/or squamous cell carcinomas of the skin, or any early stage (stage l) malignancy adequately resected for cure greater than 5 years previously)
  • Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial
  • Any psychiatric or other disorder likely to impact on informed consent

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

  • Patients may have undergone a non-curative operation (i.e., R2 resection [with macroscopic residual disease] or palliative bypass surgery only) and fully recovered

    • Patients who have previously undergone curative surgery must have evidence of non-resectable disease relapse
  • Patients may have received prior radiotherapy within the past 28 days (with or without radio-sensitizing low-dose chemotherapy) for localized disease and fully recovered

    • Must have clear evidence of disease progression prior to inclusion in this study
  • Patients may have received prior chemotherapy within the past 28 days and fully recovered

    • Must have clear evidence of disease progression prior to inclusion in this study

Exclusion criteria:

  • Previous treatment with curative intent for current disease in the last 12 weeks (i.e., prior resection, radical radiotherapy, or chemotherapy)
  • Previous treatment with experimental therapy for current disease in the last 12 weeks
  • No cytotoxic chemotherapy, radiotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), or experimental medications will be permitted for the first four weeks of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513539

Locations
United Kingdom, England
Aintree University Hospital Recruiting
Liverpool, England, United Kingdom, L9 7AL
Contact: Richard Sturgess, MD     44-151-529-2814        
Queen's Medical Centre Recruiting
Nottingham, England, United Kingdom, NG7 2UH
Contact: Krish Ragunath, MD     44-115-924-9924        
University College Hospital Recruiting
London, England, United Kingdom, NW1 2PG
Contact: Stephen P. Pereira, MD     44-845-155-5000     stephen.pereira@ucl.ac.uk    
United Kingdom, Scotland
Ninewells Hospital Recruiting
Dundee, Scotland, United Kingdom, DD1 9SY
Contact: Iain Tait, MD     44-1382-660-111        
Sponsors and Collaborators
University College London Hospitals
Investigators
Study Chair: Stephen P. Pereira, MD University College London Hospitals
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000558540, CRUK-PHOTOSTENT-02, EU-20740, EUDRACT-2005-001173-96, ISRCTN87712758, CTA-20363/0207/001-0001
Study First Received: August 6, 2007
Last Updated: August 26, 2008
ClinicalTrials.gov Identifier: NCT00513539  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unresectable gallbladder cancer
recurrent gallbladder cancer
cholangiocarcinoma of the gallbladder
unresectable extrahepatic bile duct cancer
recurrent extrahepatic bile duct cancer
cholangiocarcinoma of the extrahepatic bile duct

Study placed in the following topic categories:
Bile duct cancer, extrahepatic
Gallbladder Diseases
Cholangiocarcinoma
Biliary Tract Neoplasms
Digestive System Neoplasms
Recurrence
Gall bladder cancer
Carcinoma
Digestive System Diseases
Dihematoporphyrin Ether
Bile Duct Diseases
Biliary Tract Diseases
Gastrointestinal Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Trioxsalen
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Photosensitizing Agents
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009