Clinical trial NCT00713687: Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma
Official title: Sequential Combination of Chemotherapy With Gemcitabine/Oxaliplatin and Photodynamic Therapy in Advanced Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cholangiocarcinoma
Keywords: photodynamic therapy
PDT
gemcitabine
oxaliplatin
cholangiocarcinoma
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Münchner Studienzentrum
First posted: 2008-07-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression free survival 6 months after study start
timeFrame: 6 months after study start
Secondary outcomes:
measure: Progression free survival 12 months after study start Progression free interval Overall survival Life quality
timeFrame: Until 12 months after study start
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Technical University of Munich at the Klinikum rechts der Isar II. Medizinische Klinik Ismaninger Str. 22
Study officials:
affiliation: Head of the gastroenterological department of the Klinikum rechts der Isar
name: Matthias Ebert, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of the gastroenterological department of the Klinikum rechts der Isar
name: Roland M. Schmid, Prof. Dr.
role: STUDY_CHAIR
References:
citation: 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.