Clinical trial NCT00513539: 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
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
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2007-08-08
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall survival
timeFrame: minimum follow up 3 years or until death
Secondary outcomes:
measure: Progression-free survival every 3 months
timeFrame: minimum follow up 3 years or until death
measure: Toxicity as assessed by NCI CTC v. 3.0
timeFrame: patients followed up for minimum of 3 years
measure: 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
timeFrame: patients followed up for a minimum of 3 years
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital
state: England
city: London
country: United Kingdom
facility: University College Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
state: England
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
state: Scotland
Study officials:
affiliation: University College London Hospitals
name: Stephen P. Pereira, MD
role: STUDY_CHAIR
References: