Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas
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| ClinicalTrials.gov Identifier: NCT00003923 |
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Recruitment Status :
Completed
First Posted : February 9, 2004
Last Update Posted : March 4, 2013
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RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be effective treatment for cancer of the bile duct, gallbladder, or pancreas.
PURPOSE: Phase II trial to determine the effectiveness of photodynamic therapy in treating patients who have cancer of the bile duct, gallbladder, or pancreas.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer Pancreatic Cancer | Drug: porfimer sodium | Phase 2 |
OBJECTIVES: I. Determine the safety and efficacy of photodynamic therapy using porfimer sodium in patients with unresectable malignant bile duct obstruction.
OUTLINE: Patients are stratified according to tumor location (proximal vs distal). Patients receive porfimer sodium IV over 3-5 minutes on day 1, followed by percutaneous or endoscopic laser light treatment on day 3. Patients achieving partial response or complete response accompanied by an increase in total bilirubin or cholangitis may repeat treatment for a maximum of 3 courses. Patients are followed weekly for 1 month, and then monthly for 1 year.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 4 participants |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Study of Photodynamic Therapy With PHOTOFRIN (Porfimer Sodium) for Injection in Patients With Malignant Bile Duct Obstruction |
| Study Start Date : | March 1999 |
| Actual Primary Completion Date : | February 2002 |
| Actual Study Completion Date : | February 2002 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven malignant bile duct obstruction with obstructive jaundice Primary carcinoma of bile duct, gallbladder, or pancreas OR Metastatic bile duct disease Successful insertion of a percutaneous drain or endoscopic stent Unresectable disease OR Resectable disease but refusal of surgery Prior biliary plastic or metallic stent allowed, if requiring stent replacement due to recurrent jaundice or routine plastic stent change No erosion of biliary tumors into major blood vessels No evidence of bile duct perforation
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin at least 2 mg/dL Renal: Not specified Other: No history of allergies or hypersensitivity to porphyrins No porphyria No cholangitis or pancreatitis
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy or brachytherapy to the abdomen Surgery: See Disease Characteristics Other: No other prior or concurrent experimental or investigational drugs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003923
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Hans Gerdes, MD | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003923 |
| Other Study ID Numbers: |
99-015 P30CA008748 ( U.S. NIH Grant/Contract ) MSKCC-99015 NCI-G99-1525 |
| First Posted: | February 9, 2004 Key Record Dates |
| Last Update Posted: | March 4, 2013 |
| Last Verified: | March 2013 |
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stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer recurrent pancreatic cancer unresectable gallbladder cancer |
recurrent gallbladder cancer unresectable extrahepatic bile duct cancer recurrent extrahepatic bile duct cancer cholangiocarcinoma of the gallbladder cholangiocarcinoma of the extrahepatic bile duct adult primary cholangiocellular carcinoma |
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Pancreatic Neoplasms Gallbladder Neoplasms Bile Duct Neoplasms Cholangiocarcinoma Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Biliary Tract Neoplasms |
Biliary Tract Diseases Gallbladder Diseases Bile Duct Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Dihematoporphyrin Ether Trioxsalen Antineoplastic Agents Dermatologic Agents Photosensitizing Agents |