The purpose of this study is to determine whether the combination of bevacizumab/temsirolimus is effective in patients with advanced renal carcinoma progressing after anti-VEGF treatment
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Bevacizumab 10mg/kg intravenous every 2 weeks until disease progression, unacceptable toxicity or consent withdrawal.
Temsirolimus 25mg intravenous once weekly until disease progression, unacceptable toxicity or consent withdrawal.
General Peripheral Hospital of Athens "Alexandra"
Athens, Athens, Greece
General Hospital of Athens "Hippokratio"
Athens, Greece
Agii Anargiri Cancer Hospital, 2nd Dept of Medical Oncology
Athens, Greece
Agii Anargiri Cancer Hospital, 3rd Dept of Medical Oncology
6-month Progression Free Survival (PFS)
Proportion of patients who are progression-free at 6month evaluation from treatment initiation
Time frame: 32 months
Progression Free Survival (PFS)
PFS will be calculated from date of treatment initiation until disease progression or death (whichever occurs first)
Time frame: Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks
Overall Survival (OS)
OS will be calculated from the date of treatment initiation to the date of death or last contact
Time frame: 48 months
Response Rate (RR)
RR is defined as the overall percentage of patients with partial (PR) or complete response (CR). The evaluation of responses will be performed according to RECIST criteria
Time frame: Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks
Tumor Shrinkage
Tumor shrinkage will be computed using waterfall plots
Time frame: Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks
Adverse Events (AEs) of all participants will be recorded and assessed upon signature of the informed consent form, until 30 days after the last administration of study treatment.
Adverse Events will be graded according to the NCI CTCAE v3.0 criteria and will be reported in a frequency table according to the highest severity grade observed per patient
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Athens, Greece
Metropolitan Hospital, 1st Dept of Medical Oncology
Athens, Greece
Metropolitan Hospital, 2nd Dept of Medical Oncology
Athens, Greece
University Hospital of Patras
Rio, Patras, Greece
Papageorgiou General Hospital
Thessaloniki, Greece
Time frame: 3 years
Quality of Life (QoL) assessment
QoL will be assessed using the EORTC QLQ C-30 questionnaire. The change in the QoL during treatment will be estimated using the Wilcoxon paired t-test
Time frame: At baseline and every 8 weeks during treatment
Investigation of antiangiogenic factors (FGF, VEGF, VEGFRR)
Changes in serum levels of antiangiogenic factors during treatment and correlation to the outcome of study treatment.
Time frame: 36 months