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Phase III Randomized Study of Double Plastic Endoprosthesis Insertion With Versus Without Adjuvant Photodynamic Therapy Using Porfimer Sodium as Palliative Treatment in Patients With Unresectable Stage III-IV Cholangiocarcinoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer

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Trial Information

Phase III Randomized Study of Double Plastic Endoprosthesis Insertion With Versus Without Adjuvant Photodynamic Therapy Using Porfimer Sodium as Palliative Treatment in Patients With Unresectable Stage III-IV Cholangiocarcinoma


OBJECTIVES:

Primary

- Compare the overall survival time in patients with unresectable Bismuth type III or IV,
stage III-IV cholangiocarcinoma treated with double plastic endoprostheses insertion
with vs without adjuvant photodynamic therapy using porfimer sodium as palliative
treatment.

Secondary

- Compare the effect of these regimens on cholestasis in these patients.

- Compare the 1-year survival rate in patients treated with these regimens.

- Compare health-related quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are
stratified according to participating center.

Patients undergo endoscopic or percutaneous drainage followed by insertion of bilateral
plastic endoprostheses into the bile ducts. Patients are then randomized to 1 of 2 treatment
arms.

- Arm I: Patients receive porfimer sodium IV on day 1. Patients undergo endoscopic laser
light therapy to the tumor site on day 3.

- Arm II: Patients receive no further treatment. Quality of life is assessed at baseline
and then at weeks 2, 13, 26, 39, 52, and 65.

After completion of study treatment, patients are followed within 30-90 days.

PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed cholangiocarcinoma

- Stage III or IV disease

- Bismuth type III or IV disease

- Tumor mass or stricture on cholangiogram and CT scan

- Unresectable disease

PATIENT CHARACTERISTICS:

Performance status

- Karnofsky 30-100%

Life expectancy

- Not specified

Hematopoietic

- WBC ≥ 2,000/mm^3

- Platelet count ≥ 50,000/mm^3

- Hemoglobin ≥ 9.0 g/dL

- Hematocrit ≥ 27%

Hepatic

- PT or INR ≤ 2 times upper limit of normal (correctable with vitamin K)

- No decompensated cirrhosis

Renal

- Not specified

Other

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known porphyria or hypersensitivity to porphyrin

- No clinically significant acute or chronic medial or psychological illness that would
preclude study treatment

- No other malignancy within the past 5 years except carcinoma in situ of the cervix or
basal cell skin cancer

- No concurrent untreated primary diagnosis of anxiety or depression

PRIOR CONCURRENT THERAPY:

Chemotherapy

- More than 13 weeks since prior and no concurrent chemotherapy

Radiotherapy

- More than 13 weeks since prior and no concurrent brachytherapy or radiotherapy

Surgery

- No prior metal stent insertion

- No prior surgical resection of cholangiocarcinoma

Other

- No prior photodynamic therapy for this disease

- More than 60 days since prior investigational drugs

- No concurrent administration of the following:

- Ursodiol

- Herbal products that may increase bile flow, including any of the following:

- Andrographis paniculata

- Chelidonium majus L

- Curcumin L

- Cynara scolymus L (artichoke)

- Gentiana lutea

- Mentha x piperita (peppermint)

- Peumus boldus Mol

- Taraxacum officinale (dandelion)

- No administration of any of the following within 7 days of porfimer sodium injection:

- Supplements in vitamins C, E, and β-carotene

- Camellia sinensis (green tea)

- Silymarin

- EGb761

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

James Farrell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

AXCAN-PHOCCC04-01

NCT ID:

NCT00253617

Start Date:

Completion Date:

Related Keywords:

  • Cholangiocarcinoma of the Extrahepatic Bile Duct
  • Cholangiocarcinoma of the Gallbladder
  • Unresectable Extrahepatic Bile Duct Cancer
  • Unresectable Gallbladder Cancer
  • Recurrent Extrahepatic Bile Duct Cancer
  • Recurrent Gallbladder Cancer
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Cholangiocarcinoma

Name

Location

Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781