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

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ClinicalTrials.gov Identifier: NCT00003923

Recruitment Status : Completed

First Posted : February 9, 2004

Last Update Posted : March 4, 2013

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Memorial Sloan Kettering Cancer Center

Tracking Information

First Submitted Date ^ICMJE

November 1, 1999

First Posted Date ^ICMJE

February 9, 2004

Last Update Posted Date

March 4, 2013

Study Start Date ^ICMJE

March 1999

Actual Primary Completion Date

February 2002 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase II Study of Photodynamic Therapy With PHOTOFRIN (Porfimer Sodium) for Injection in Patients With Malignant Bile Duct Obstruction

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Liver Cancer
Pancreatic Cancer

Intervention ^ICMJE

Drug: porfimer sodium

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

Original Enrollment ^ICMJE

Not Provided

Actual Study Completion Date ^ICMJE

February 2002

Actual Primary Completion Date

February 2002 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00003923

Other Study ID Numbers ^ICMJE

99-015
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-99015
NCI-G99-1525

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Not Provided

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Memorial Sloan Kettering Cancer Center

Original Study Sponsor ^ICMJE

National Cancer Institute (NCI)

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Hans Gerdes, MD

Memorial Sloan Kettering Cancer Center

PRS Account

Memorial Sloan Kettering Cancer Center

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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