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

This study has been withdrawn prior to enrollment.
(recruiting failed)
Sponsor:
Collaborator:
Münchner Studienzentrum
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00713687
First received: July 7, 2008
Last updated: August 9, 2012
Last verified: July 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sequential Combination of Chemotherapy With Gemcitabine/Oxaliplatin and Photodynamic Therapy in Advanced Cholangiocarcinoma

Resource links provided by NLM:


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 ]

Enrollment: 0
Study Start Date: August 2008
Estimated Study Completion Date: December 2011
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00713687     History of Changes
Other Study ID Numbers: GEM-658-EBE-0024-I, EudraCT-Nr.: 2008-001560-37
Study First Received: July 7, 2008
Last Updated: August 9, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
photodynamic therapy
PDT
gemcitabine
oxaliplatin
cholangiocarcinoma

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 26, 2014