search
Back to results

Stent Placement With or Without Photodynamic Therapy Using Porfimer Sodium as Palliative Treatment in Treating Patients With Stage III or Stage IV Cholangiocarcinoma That Cannot Be Removed By Surgery

Primary Purpose

Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder, Unresectable Extrahepatic Bile Duct Cancer

Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
porfimer sodium
adjuvant therapy
laser therapy
photodynamic therapy
phototherapy
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiocarcinoma of the Extrahepatic Bile Duct

Eligibility Criteria

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

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA
  • Axcan Pharma, Incorporated

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 11, 2005
Last Updated
April 2, 2013
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00253617
Brief Title
Stent Placement With or Without Photodynamic Therapy Using Porfimer Sodium as Palliative Treatment in Treating Patients With Stage III or Stage IV Cholangiocarcinoma That Cannot Be Removed By Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Stent placement may help reduce symptoms caused by the tumor. Photodynamic therapy uses a drug, such as porfimer sodium, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for cholangiocarcinoma. It is not yet known whether stent placement and photodynamic therapy using porfimer sodium are more effective than stent placement alone in treating cholangiocarcinoma. PURPOSE: This randomized phase III trial is studying stent placement and photodynamic therapy using porfimer sodium to see how well they work compared to stent placement alone as palliative treatment in treating patients with stage III or stage IV cholangiocarcinoma that cannot be removed by surgery.
Detailed Description
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
porfimer sodium
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
laser therapy
Intervention Type
Procedure
Intervention Name(s)
photodynamic therapy
Intervention Type
Procedure
Intervention Name(s)
phototherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Farrell, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Axcan Pharma, Incorporated
City
Mont-Saint-Hilaire
State/Province
Quebec
ZIP/Postal Code
J3H 6C4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Stent Placement With or Without Photodynamic Therapy Using Porfimer Sodium as Palliative Treatment in Treating Patients With Stage III or Stage IV Cholangiocarcinoma That Cannot Be Removed By Surgery

We'll reach out to this number within 24 hrs