Last updated on September 2017

Clinical Trial to Investigate the Efficacy of Treatment With Gemcitabine/Pazopanib in Patients With Biliary Tree Cancer


Brief description of study

The purpose of this study is to determine whether gemcitabine and pazopanib are effective in the treatment of inoperable, locally advanced or metastatic biliary tree cancer (cholangiocarcinoma or gallbladder carcinoma).

Detailed Study Description

This is an open label, uncontrolled, multicenter, phase II study to evaluate the efficacy and safety of Gemcitabine/Pazopanib combination as 1st line treatment in patients with unresectable, locally advanced or metastatic biliary tree adenocarcinoma. A total of 46 patients will be included in the study. The patients will receive open label Gemcitabine 1000 mg/m2 intravenously on days 1 and 8 and Pazopanib 800 mg per os on days 1 to 21 every 21 days. Treatment with gemcitabine/pazopanib combination will continue until disease progression, appearance of significant toxicity, completion of 8 cycles or informed consent withdrawal. Upon completion of 8 treatment cycles with the combination, and in the absence of disease progression, administration of pazopanib monotherapy as maintenance treatment will be continued until disease progression, appearance of significant toxicity or informed consent withdrawal. Imaging assessments will be performed every 8 weeks

Clinical Study Identifier: NCT01855724

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George Koumakis, MD

2nd Dept of Internal Medicine, Agios Savvas Cancer Hospital
Athens, Greece
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Nikolaos Kentepozidis, MD

Dept of Medical Oncology, 251 General Air Force Hospital
Athens, Greece
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Dimitrios Pectasides, Professor

2nd Dept of Internal Medicine, General Hospital of Athens "Hippokratio"
Athens, Greece
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Christos Papadimitriou, Ass.Prof.

Oncology Section, Dept of Clinical Therapeutics, General Hospital of Athens "Alexandra"
Athens, Greece
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Diamanto Psyrri, Lecturer

Division of Oncology, 2nd Dept of Internal Medicine, Propaedeutic, University Hospital "Attikon"
Athens, Greece
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Gerasimos Aravantinos, MD

2nd Dept of Medical Oncology, Agii Anargiri Cancer Hospital
Athens, Greece
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Joseph Sgouros, MD

3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital
Athens, Greece
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Evangelia Razis, MD

3rd Dept of Medical Oncology, Hygeia Hospital
Athens, Greece
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Dimitrios Bafaloukos, MD

1st Dept of Medical Oncology, Metropolitan Hospital
Athens, Greece
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Christos Christodoulou, MD

2nd Dept of Medical Oncology, Metropolitan Hospital
Athens, Greece
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Athanasios Kotsakis, Ass.Prof

Dept of Medical Oncology, University Hospital of Heraklion
Heraklio, Greece
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George Pentheroudakis, Ass.Prof.

Dept of Medical Oncology, Ioannina University Hospital
Ioannina, Greece
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Thomas Makatsoris, Lecturer

Division of Oncology, Dept of Internal Medicine, University Hospital of Patras
Patras, Greece
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Vasilios Karavasilis, Ass.Prof

Dept of Medical Oncology, Papageorgiou General Hospital
Thessaloniki, Greece
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George Fountzilas, Professor

Dept of Medical Oncology, Thermi Clinic S.A
Thessaloniki, Greece
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