Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma

NCT00713687 | Withdrawn Phase 2

• 2 other identifiers: GEM-658-EBE-0024-IEudraCT-Nr.: 2008-001560-37
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma

Keywords

photodynamic therapy; PDT; gemcitabine; oxaliplatin; cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival 6 months after study start

  6 months after study start

Secondary Outcomes (1)

• Progression free survival 12 months after study start Progression free interval Overall survival Life quality

  Until 12 months after study start

Study Arms (1)

1

EXPERIMENTAL

Treatment by combination of photodynamic therapy and chemotherapy

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

Interventions

Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®) 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

Also known as: No other names

1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead
• Münchner Studienzentrum: collaborator

Study Sites (1)

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

Munich, 81675, Germany

Location

Related 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.

  BACKGROUND

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Gemcitabine; Oxaliplatin; Photochemotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Matthias Ebert, Prof. Dr.

  Head of the gastroenterological department of the Klinikum rechts der Isar

  PRINCIPAL INVESTIGATOR

• Roland M. Schmid, Prof. Dr.

  Head of the gastroenterological department of the Klinikum rechts der Isar

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 11, 2008
• Study Start: August 1, 2008
• Study Completion: December 1, 2011
• Last Updated: August 10, 2012

Record last verified: 2008-07

Locations

DE (1)