Efficacy and Safety of Bevacizumab/Temsirolimus Combination to Treat Advanced Renal Cell Carcinoma
Conditions
Kidney Cancer
Study Type
Interventional
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
Intervention
Name: Bevacizumab Type: Drug
Name: Temsirolimus Type: Drug
Overall Status
Recruiting
Summary
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.
Locations
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
Sponsors
Hellenic Cooperative Oncology Group
Source
Hellenic Cooperative Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page