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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 (Photostent-02)

Primary Purpose

Extrahepatic Bile Duct Cancer, Gallbladder Cancer

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
porfimer sodium
biliary stenting
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aintree University Hospital
  • University College Hospital
  • Queen's Medical Centre
  • Ninewells Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A

Arm B

Arm Description

Biliary Stenting alone

Photodynamic Therapy plus biliary stenting

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Progression-free survival every 3 months
Toxicity as assessed by NCI CTC v. 3.0
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

Full Information

First Posted
August 6, 2007
Last Updated
February 18, 2013
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT00513539
Brief Title
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
Acronym
Photostent-02
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Biliary Stenting alone
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Photodynamic Therapy plus biliary stenting
Intervention Type
Drug
Intervention Name(s)
porfimer sodium
Intervention Type
Procedure
Intervention Name(s)
biliary stenting
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
minimum follow up 3 years or until death
Secondary Outcome Measure Information:
Title
Progression-free survival every 3 months
Time Frame
minimum follow up 3 years or until death
Title
Toxicity as assessed by NCI CTC v. 3.0
Time Frame
patients followed up for minimum of 3 years
Title
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
Time Frame
patients followed up for a minimum of 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen P. Pereira, MD
Organizational Affiliation
University College London Hospitals
Official's Role
Study Chair
Facility Information:
Facility Name
Aintree University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
University College Hospital
City
London
State/Province
England
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom

12. IPD Sharing Statement

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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

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