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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Extrahepatic Bile Duct Cancer, Gallbladder Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

minimum follow up 3 years or until death

Safety Issue:

No

Principal Investigator

Stephen P. Pereira, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University College London Hospitals

Authority:

United Kingdom : Medicines and Healthcare Research Authority (MHRA)

Study ID:

CDR0000558540

NCT ID:

NCT00513539

Start Date:

July 2007

Completion Date:

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • 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
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Cholangiocarcinoma

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