Efficacy and Safety of Bevacizumab/Temsirolimus Combination to Treat Advanced Renal Cell Carcinoma
Kidney Cancer
Study Type
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Bevacizumab Type: Drug
Name: Temsirolimus Type: Drug
Overall Status
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Adult patients (18th year of age completed)

- Signed and dated written informed consent form prior to any procedures related to this protocol.

- 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.

Exclusion Criteria:

- 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 cervix).

- 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 medicinal products.

- History of chronic interstitial lung disease.
Agii Anargiri Cancer Hospital, 2nd Dept of Medical Oncology
Athens, Greece
Status: Recruiting
Contact: Gerassimos Aravantinos, MD - 0030 210 3501278 - bpstudies@yahoo.gr
Agii Anargiri Cancer Hospital, 3rd Dept of Medical Oncology
Athens, Greece
Status: Recruiting
Contact: Anastasios Visvikis, MD - hecogaga@otenet.gr
General Hospital of Athens "Hippokratio"
Athens, Greece
Status: Not yet recruiting
Contact: Dimitrios Pectasides, MD - pectasid@otenet.gr
General Peripheral Hospital of Athens "Alexandra"
Athens, Greece
Status: Recruiting
Contact: Aristotelis Bamias, MD - abamias@med.uoa.gr
Metropolitan Hospital, 1st Dept of Medical Oncology
Athens, Greece
Status: Recruiting
Contact: Dimitrios Bafaloukos, MD - dimmp@otenet.gr
Metropolitan Hospital, 2nd Dept of Medical Oncology
Athens, Greece
Status: Recruiting
Contact: Eleni Galani, MD - eleni_galani@yahoo.gr
University Hospital of Patras
Rio, Patras, Greece
Status: Recruiting
Contact: Angelos Koutras, MD - angkoutr@otenet.gr
Papageorgiou General Hospital
Thessaloniki, Greece
Status: Recruiting
Contact: George Fountzilas, MD - fountzil@auth.gr
Start Date
December 2010
Completion Date
December 2015
Hellenic Cooperative Oncology Group
Hellenic Cooperative Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page