Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma

Cholangiocarcinoma Clinical Trial

— GemOx-PDT  

Official title:

Sequential Combination of Chemotherapy With Gemcitabine/Oxaliplatin and Photodynamic Therapy in Advanced Cholangiocarcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00713687
• Other study ID #: GEM-658-EBE-0024-I
• Secondary ID: EudraCT-Nr.: 200
• Status: Withdrawn
• Phase: Phase 2
• First received: July 7, 2008
• Last updated: August 9, 2012
• Start date: August 2008
• Est. completion date: December 2011

Study information

• Verified date: July 2008
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

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

Locations

Country	Name	City	State
Germany	Technical University of Munich at the Klinikum rechts der Isar II. Medizinische Klinik Ismaninger Str. 22	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität München	Münchner Studienzentrum

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival 6 months after study start		6 months after study start
Secondary	Progression free survival 12 months after study start Progression free interval Overall survival Life quality		Until 12 months after study start