GemOx-PDT: Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma

Sponsor

Technische Universität München (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00713687

Collaborator

Münchner Studienzentrum (Other)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Aug 1, 2008

Study Completion Date :

Dec 1, 2011

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Treatment by combination of photodynamic therapy and chemotherapy

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

Other Names:

No other names

Outcome Measures

Primary Outcome Measures

Progression free survival 6 months after study start [6 months after study start]

Secondary Outcome Measures

Progression free survival 12 months after study start Progression free interval Overall survival Life quality [Until 12 months after study start]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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