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).
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
2nd Dept of Internal Medicine, Agios Savvas Cancer Hospital
Athens, Greece
Dept of Medical Oncology, 251 General Air Force Hospital
Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Imaging evaluation for the determination of response to treatment will be performed every 8 weeks
Time frame: At an average of 6 months for each patient
Evaluation of Progression-Free Survival (PFS)
Time frame: PFS will be calculated from the date of treatment initiation to the date of disease progression or date of death, assessed up to 48 months
Evaluation of 6-month Progression-Free Survival rate (6-month PFS rate)
The aim is to determine the rate of PFS in patients, at 6 months of treatment
Time frame: Assessed up to 6 months
Evaluation of Overall Survival (OS)
Time frame: OS will be calculated from the date of treatment initiation to the date of death from any cause, assessed up to 48 months.
Assessment of safety and tolerability
Distribution of Adverse Events (AEs) according to severity grade. Evaluation of AEs will be performed every 21 days (per treatment cycle) throughout the course of treatment
Time frame: Assessed up to 48 months
Evaluation of Quality of Life (QoL)
Quality of Life Questionnaires will be filled out before treatment initiation, every 8 weeks and at the end of treatment
Time frame: Assessed up to 9 months
Evaluation of potential prognostic and/or predictive biomarkers in tissue and blood samples
The following biomarkers will be analyzed: In bioptic material: * Stem Cell Factor (KIT) * Vascular Endothelial Growth Factor Receptor-2 (VEGF-2) * Vascular Endothelial Growth Factor Receptor-3 (VEGF-3) In peripheral blood/plasma: * Interleukin 8 * Interleukin 12 * Hepatocyte growth factor There may be additions to the biomarkers to be analyzed, dependent on the clinical and bibliographical data
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Athens, Greece
2nd Dept of Internal Medicine, General Hospital of Athens "Hippokratio"
Athens, Greece
Oncology Dept, 2nd Surgyc Clinic, Aretaieio Hospital
Athens, Greece
Oncology Section, Dept of Clinical Therapeutics, General Hospital of Athens "Alexandra"
Athens, Greece
Division of Oncology, 2nd Dept of Internal Medicine, Propaedeutic, University Hospital "Attikon"
Athens, Greece
2nd Dept of Medical Oncology, Agii Anargiri Cancer Hospital
Athens, Greece
3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital
Athens, Greece
3rd Dept of Medical Oncology, Hygeia Hospital
Athens, Greece
1st Dept of Medical Oncology, Metropolitan Hospital
Athens, Greece
...and 7 more locations
Time frame: Tumor blocks and blood samples will be collected at baseline