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

NCT00513539 | Completed Phase 3 DMC

• 6 other identifiers: CDR0000558540CRUK-PHOTOSTENT-02EU-20740EUDRACT-2005-001173-96ISRCTN87712758CTA-20363/0207/001-0001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Extrahepatic Bile Duct Cancer; Gallbladder Cancer

Keywords

unresectable gallbladder cancer; recurrent gallbladder cancer; metastatic gallbladder cancer; cholangiocarcinoma of the gallbladder; unresectable extrahepatic bile duct cancer; recurrent extrahepatic bile duct cancer; metastatic extrahepatic bile duct cancer; cholangiocarcinoma of the extrahepatic bile duct

Outcome Measures

Primary Outcomes (1)

• Overall survival

  minimum follow up 3 years or until death

Secondary Outcomes (3)

• Progression-free survival every 3 months

  minimum follow up 3 years or until death

• Toxicity as assessed by NCI CTC v. 3.0

  patients followed up for minimum of 3 years

• 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

  patients followed up for a minimum of 3 years

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Biliary Stenting alone

Procedure: biliary stenting

Arm B

EXPERIMENTAL

Photodynamic Therapy plus biliary stenting

Drug: porfimer sodium; Procedure: biliary stenting

Interventions

porfimer sodium DRUG

Arm B

biliary stenting PROCEDURE

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Porphyria
• No brain metastases
• PATIENT CHARACTERISTICS:
• 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
• 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:
• 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
• Patients may have received prior chemotherapy within the past 28 days and fully recovered

Sponsors & Collaborators

• University College, London: lead

Study Sites (4)

Aintree University Hospital

Liverpool, England, L9 7AL, United Kingdom

Location

University College Hospital

London, England, NW1 2PG, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Bile Duct Neoplasms; Gallbladder Neoplasms

Interventions

Dihematoporphyrin Ether

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Hematoporphyrin Derivative; Hematoporphyrins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pigments, Biological; Biological Factors

Study Officials

• Stephen P. Pereira, MD

  University College London Hospitals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 8, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2009
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

GB (4)