Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma (GemOx-PDT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00713687
Recruitment Status : Withdrawn (recruiting failed)
First Posted : July 11, 2008
Last Update Posted : August 10, 2012
Münchner Studienzentrum
Information provided by:
Technische Universität München

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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Drug: Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sequential Combination of Chemotherapy With Gemcitabine/Oxaliplatin and Photodynamic Therapy in Advanced Cholangiocarcinoma
Study Start Date : August 2008
Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: 1
Treatment by combination of photodynamic therapy and chemotherapy
Drug: 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
Other Name: No other names

Primary Outcome Measures :
  1. Progression free survival 6 months after study start [ Time Frame: 6 months after study start ]

Secondary Outcome Measures :
  1. Progression free survival 12 months after study start Progression free interval Overall survival Life quality [ Time Frame: Until 12 months after study start ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00713687

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
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

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. Identifier: NCT00713687     History of Changes
Other Study ID Numbers: GEM-658-EBE-0024-I
EudraCT-Nr.: 2008-001560-37
First Posted: July 11, 2008    Key Record Dates
Last Update Posted: August 10, 2012
Last Verified: July 2008

Keywords provided by Technische Universität München:
photodynamic therapy

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs