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

NCT00253617 | Withdrawn Phase 3

• 3 other identifiers: AXCAN-PHOCCC04-01UCLA-0501033-01CDR0000449701
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

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.

Conditions

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

Interventions

porfimer sodium DRUG

adjuvant therapy PROCEDURE

laser therapy PROCEDURE

photodynamic therapy PROCEDURE

phototherapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Axcan Pharma, Incorporated

Mont-Saint-Hilaire, Quebec, J3H 6C4, Canada

Location

MeSH Terms

Conditions

Bile Duct Neoplasms; Gallbladder Neoplasms

Interventions

Dihematoporphyrin Ether; Chemotherapy, Adjuvant; Laser Therapy; Photochemotherapy; Phototherapy

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Hematoporphyrin Derivative; Hematoporphyrins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pigments, Biological; Biological Factors; Combined Modality Therapy; Therapeutics; Drug Therapy; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• James Farrell, MD

  Jonsson Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 11, 2005
• First Posted: November 15, 2005
• Last Updated: April 4, 2013

Record last verified: 2006-12

Locations

US (1); CA (1)