Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma

NCT ID: NCT00713687

Last Updated: 2012-08-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-12-31

Brief Summary

In patients with cholangiocarcinoma therapeutic effects have been reported for Gemcitabine/Oxaliplatin. Furthermore, photodynamic therapy (PDT) has significantly improved patients survival in two randomised trials. PDT induces tumor necrosis only in an area of few millimetres, while tumor parts which are located beyond this area remain untreated. An additive effect could result from PDT as a local therapy in combination with systemic chemotherapy.

Detailed Description

Patients entered in the study receive a sequential therapy consisted of photodynamic therapy followed by systemic chemotherapy (Gemcitabine/Oxaliplatin) 4 weeks later. Systemic chemotherapy every 2 weeks is scheduled 9 times in each cycle. Thereafter, another cycle of PDT followed by chemotherapy is intended.

Conditions

Cholangiocarcinoma

Keywords

photodynamic therapy; PDT; gemcitabine; oxaliplatin; cholangiocarcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Treatment by combination of photodynamic therapy and chemotherapy

Group Type: EXPERIMENTAL

Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®)

Intervention Type: DRUG

1. Photodynamic therapy (PDT) after successful drainage:

Photosan® 2 mg/kg i.v. 48 hrs before laser activation

2. 9 cycles of GemOx chemotherapy (start 4 weeks after PDT):

• Gemcitabine 1000 mg/m² 100 min infusion on day 1 of chemotherapy
• Oxaliplatin 100 mg/m² 2h infusion on day 2 of chemotherapy
• iteration every 14 days
• afterwards 4 weeks intermission

3. Iteration of 1. and 2. in case of good compatibility

Interventions

Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®)

1. Photodynamic therapy (PDT) after successful drainage:

Photosan® 2 mg/kg i.v. 48 hrs before laser activation

2. 9 cycles of GemOx chemotherapy (start 4 weeks after PDT):

• Gemcitabine 1000 mg/m² 100 min infusion on day 1 of chemotherapy
• Oxaliplatin 100 mg/m² 2h infusion on day 2 of chemotherapy
• iteration every 14 days
• afterwards 4 weeks intermission

3. Iteration of 1. and 2. in case of good compatibility

Intervention Type: DRUG

Other Intervention Names

No other names

Eligibility Criteria

Inclusion Criteria

• Histologic/cytologic verified cholangiocarcinoma or cholangiocarcinoma-typical findings in >= 2 diagnostic methods
• Bile duct stenoses which are technically successful treated with biliary drainage
• Irresectability/inoperability
• Karnofsky-Index >= 60%
• Age >= 18
• Written consent

Before chemotherapy:

• Bilirubin <= 5 mg/dl
• GOT/GPT < 5x upper standard
• Creatinine < 2x upper standard
• Thrombocytes > 100 G/l
• Neutrophils > 2,00 G/l
• Haemoglobin > 9 g/dl
• No occurence of complications during endoscopic procedures (abscess, bilioma, cholecystitis, cholangitis, pancreatitis, biliary leakage)

Exclusion Criteria

• Implantation of a metal stent in the bile duct
• Previous PDT or chemotherapy
• Neoplasia
• Porphyria
• Pregnant or breastfeeding women
• Women of childbearing age and potent men who are not using highly effective contraceptives

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Münchner Studienzentrum

UNKNOWN

Sponsor Role: collaborator

Technical University of Munich

OTHER

Sponsor Role: lead

Principal Investigators

Matthias Ebert, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Head of the gastroenterological department of the Klinikum rechts der Isar

Roland M. Schmid, Prof. Dr.

Role: STUDY_CHAIR

Head of the gastroenterological department of the Klinikum rechts der Isar

Locations

Technical University of Munich at the Klinikum rechts der Isar II. Medizinische Klinik Ismaninger Str. 22

Munich, , Germany

Countries

Germany

References

Rajagopalan V, Daines WP, Grossbard ML, Kozuch P. Gallbladder and biliary tract carcinoma: A comprehensive update, Part 1. Oncology 2004;18:889-896. Patel T. Cholangiocarcinoma. Nat Clin Pract Gastroenterol Hepatol 2006;3:33-42. de Groen PC, Gores GJ, LaRusso NF, Gunderson LL, Nagorney DM. Biliary tract cancers. N Engl J Med. 1999;341:1368-1378. Eckel F, Schmid RM. Chemotherapy in advanced biliary tract carcinoma: a pooled analysis of clinical trials. Br J Cancer 2007;96:896-902. Ortner ME, Caca K, Berr F, Liebetruth J, Mansmann U, Huster D, Voderholzer W, Schachschal G, Mössner J, Lochs H. Successful photodynamic therapy for nonresectable cholangiocarcinoma: a randomized prospective study. Gastroenterology 2003;125:1355-1363. Zoepf T, Jakobs R, Arnold JC, Apel D, Riemann JF. Palliation of nonresectable bile duct cancer: improved survival after photodynamic therapy. Am J Gastroenterol 2005;100:2426-2430. Wiedmann M, Caca K, Berr F, Schiefke I, Tannapfel A, Wittekind C, Mössner J, Hauss J, Witzigmann H. Neoadjuvant photodynamic therapy as a new approach to treating hilar cholangiocarcinoma: a phase II pilot study. Cancer. 2003;97:2783-2790. Dougherty TJ, Gomer CJ, Henderson BW, Jori G, Kessel D, Korbelik M, Moan J, Peng Q. Photodynamic therapy. J Natl Cancer Inst. 1998;90:889-905. Gollnick SO, Vaughan L, Henderson BW. Generation of effective antitumor vaccines using photodynamic therapy. Cancer Res 2002;62:1604-1608. Wiedmann M, Berr F, Schiefke I, Witzigmann H, Kohlhaw K, Mössner J, Caca K. Photodynamic therapy in patients with non-resectable hilar cholangiocarcinoma: 5-year follow-up of a prospective phase II study. Gastrointest Endosc 2004;60:68-75.

Reference Type: BACKGROUND

Other Identifiers

EudraCT-Nr.: 2008-001560-37

Identifier Type: -

Identifier Source: secondary_id

GEM-658-EBE-0024-I

Identifier Type: -

Identifier Source: org_study_id