Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma - Full Text View

Sponsors and Collaborators:	Technische Universität München Münchner Studienzentrum
Information provided by:	Technische Universität München
ClinicalTrials.gov Identifier:	NCT00713687

Purpose

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.

Condition	Intervention	Phase
Cholangiocarcinoma	Drug: Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®)	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Oxaliplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Sequential Combination of Chemotherapy With Gemcitabine/Oxaliplatin and Photodynamic Therapy in Advanced Cholangiocarcinoma

Further study details as provided by Technische Universität München:

Primary Outcome Measures:

Progression free survival 6 months after study start [ Time Frame: 6 months after study start ]

Secondary Outcome Measures:

Progression free survival 12 months after study start Progression free interval Overall survival Life quality [ Time Frame: Until 12 months after study start ]

Estimated Enrollment:	24
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2011

Arms	Assigned Interventions
1: Experimental Treatment by combination of photodynamic therapy and chemotherapy	Drug: Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®) Photodynamic therapy (PDT) after successful drainage: Photosan® 2 mg/kg i.v. 48 hrs before laser activation 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 Iteration of 1. and 2. in case of good compatibility

Arms

Assigned Interventions

1: Experimental

Treatment by combination of photodynamic therapy and chemotherapy

Drug: Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®)

Photodynamic therapy (PDT) after successful drainage:

Photosan® 2 mg/kg i.v. 48 hrs before laser activation
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
Iteration of 1. and 2. in case of good compatibility

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713687

Contacts

Contact: Matthias Ebert, Prof. Dr.	+49-(0)89-4140-4872	matthias.ebert@lrz.tum.de
Contact: Roland Schmitt, Prof. Dr.

Locations

Germany
Technical University of Munich at the Klinikum rechts der Isar II. Medizinische Klinik Ismaninger Str. 22
Munich, Germany, 81675

Sponsors and Collaborators

Technische Universität München

Münchner Studienzentrum

Investigators

Principal Investigator:	Matthias Ebert, Prof. Dr.	Head of the gastroenterological department of the Klinikum rechts der Isar
Study Chair:	Roland M. Schmid, Prof. Dr.	Head of the gastroenterological department of the Klinikum rechts der Isar

More Information

Publications:

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. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000;92:205-216.

Study ID Numbers:	GEM-658-EBE-0024-I, EudraCT-Nr.: 2008-001560-37
Study First Received:	July 7, 2008
Last Updated:	July 10, 2008
ClinicalTrials.gov Identifier:	NCT00713687 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by Technische Universität München:

photodynamic therapy
PDT
gemcitabine
oxaliplatin
cholangiocarcinoma

Study placed in the following topic categories:

Antimetabolites
Cholangiocarcinoma
Oxaliplatin
Radiation-Sensitizing Agents
Immunologic Factors
Gemcitabine

Adenocarcinoma
Immunosuppressive Agents
Antiviral Agents
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Cholangiocarcinoma
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents

Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Oxaliplatin
Radiation-Sensitizing Agents
Therapeutic Uses
Adenocarcinoma
Gemcitabine
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009