Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00003923
First received: November 1, 1999
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Liver Cancer
Pancreatic Cancer
Drug: porfimer sodium
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Photodynamic Therapy With PHOTOFRIN (Porfimer Sodium) for Injection in Patients With Malignant Bile Duct Obstruction

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Enrollment: 4
Study Start Date: March 1999
Study Completion Date: February 2002
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00003923

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Hans Gerdes, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003923     History of Changes
Other Study ID Numbers: 99-015, P30CA008748, MSKCC-99015, NCI-G99-1525
Study First Received: November 1, 1999
Last Updated: March 1, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Liver Neoplasms
Bile Duct Neoplasms
Gallbladder Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Liver Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Gallbladder Diseases
Trioxsalen
Dihematoporphyrin Ether
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014