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

Technical University of Munich

Status and phase: Withdrawn; Phase 2

Conditions: Cholangiocarcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00713687

EudraCT-Nr.: 2008-001560-37

GEM-658-EBE-0024-I

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

1

Experimental group

Description:

Treatment by combination of photodynamic therapy and chemotherapy

Treatment:

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