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| Sponsor: | Jonsson Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00253617 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Drug: porfimer sodium Procedure: adjuvant therapy Procedure: laser therapy Procedure: photodynamic therapy Procedure: phototherapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 |
OBJECTIVES:
Primary
Secondary
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Canada, Quebec | |
| Axcan Pharma, Incorporated | |
| Mont-Saint-Hilaire, Quebec, Canada, J3H 6C4 | |
| Study Chair: | James Farrell, MD | Jonsson Comprehensive Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00253617 History of Changes |
| Other Study ID Numbers: | CDR0000449701, UCLA-0501033-01, AXCAN-PHOCCC04-01 |
| Study First Received: | November 11, 2005 |
| Last Updated: | December 4, 2006 |
| Health Authority: | United States: Federal Government |
|
Gallbladder Neoplasms Bile Duct Neoplasms Cholangiocarcinoma Biliary Tract Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases Bile Duct Diseases Adenocarcinoma Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adjuvants, Immunologic Trioxsalen Dihematoporphyrin Ether Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Photosensitizing Agents Radiation-Sensitizing Agents Dermatologic Agents Therapeutic Uses Antineoplastic Agents |