Phase II Study of Efficacy and Safety of Bevacizumab in Combination With Temsirolimus, After 1st Line Anti-VEGF Treatment in Patients With Advanced Renal Cancer
- Adult patients (18th year of age completed)
- Signed and dated written informed consent form prior to any procedures related to
- Histologically confirmed advanced clear cell renal cancer.
- Measurable disease.
- Failure of first line anti-VEGF treatment.
- Performance status 0-2, according to Eastern Cooperative Oncology Group (ECOG) .
- Satisfactory hematological parameters:
- White blood cell count > 4000 mm3.
- Platelet count 100000/mm3.
- Neutrophil blood cell count > 1200/ mm3 .
- Hemoglobin > 9,0 g/dL (can be achieved with red blood cell transfusion).
- Satisfactory biochemical parameters:
- Serum creatinine < 2 x Upper Limit of Normal(ULN)
- Aspartate Aminotransferase (AST)<2,5 x ULN
- Alanine Transaminase (ALT)< 2,5 x ULN.
- Bilirubin <2 x ULN
- (For female patients) Absence of pregnancy (negative pregnancy test for women of
reproductive age before enrollment).
- (For female patients) Non-lactating women.
- Use of efficient contraceptive measures (women and men) to prevent possible pregnancy
of female patient or female partner of a male patient during treatment and until 6
months after the end of treatment.
- Prior treatment with mTOR inhibitor.
- Major surgery (including open biopsy) or insufficient recovery or existence of major
trauma within 4 weeks before enrollment.
- Uncontrolled hypertension.
- Active infection requiring systemic treatment within 4 weeks prior to enrollment.
- Minor surgery (for instance, catheter placement) within 2 days before enrollment.
- Scheduled major surgery within the treatment period.
- Medical history in the last 6 months prior to enrollment of significant
cardiovascular disease, diabetes, cardiac infarction, unstable angina, uncontrolled
arrhythmia or significant heart failure.
- Indications of uncontrolled metastases or disease progression in CNS lesions (the
suspicion of uncontrolled metastases or disease progression should be eliminated by
imaging techniques within 14 days prior to enrollment).
- Medical history in the last 5 years prior to enrollment of any other malignancies
(excluding the basal or squamous skin cell carcinoma or in situ carcinoma of the
- History of non-healing wound including active gastric ulcer.
- History of fistula in the last 6 months prior to enrollment.
- History of gastrointestinal perforations.
- Patient incapacity (for psychiatric or social reasons) to conform with the protocol.
- History of hemorrhagic predisposition.
- History of hypersensitivity to the medications under investigation.
- Significant proteinurea.
- Prior immunotherapy within 4 weeks prior to enrollment.
- Prior radiation treatment within 2 weeks prior to enrollment.
- Concomitant medication with inducers or strong inhibitors of the coenzyme CYP3A4 (see
Appendix 5 for an indicative list of active compounds).
- Concurrent participation in other interventional clinical trials with investigational
- History of chronic interstitial lung disease.