Status:
TERMINATED
Efficacy and Safety of Bevacizumab/Temsirolimus Combination to Treat Advanced Renal Cell Carcinoma
Lead Sponsor:
Hellenic Cooperative Oncology Group
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01264341
Start Date
December 1 2010
End Date
July 1 2015
Last Update
February 14 2017
Active Locations (8)
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1
General Peripheral Hospital of Athens "Alexandra"
Athens, Athens, Greece, 11528
2
General Hospital of Athens "Hippokratio"
Athens, Greece, 11527
3
Agii Anargiri Cancer Hospital, 2nd Dept of Medical Oncology
Athens, Greece, 14564
4
Agii Anargiri Cancer Hospital, 3rd Dept of Medical Oncology
Athens, Greece, 14564