NCT00713687

Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholangiocarcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-08-01
• Completion: 2011-12-01
• First posted: 2008-07-11
• Last updated: 2012-08-10

Locations

1 site across 1 country: Germany