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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

Phase 2
18 Years
Open (Enrolling)
Kidney Cancer

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6-month Progression Free Survival (PFS)

Outcome Description:

Proportion of patients who are progression-free at 6month evaluation from treatment initiation

Outcome Time Frame:

32 months

Safety Issue:


Principal Investigator

Aristotelis Bamias, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

General Peripheral Hospital of Athens "Alexandra", Medical School, University of Athens


Greece:National Organization for Medicines

Study ID:

HE 21/10



Start Date:

December 2010

Completion Date:

October 2014

Related Keywords:

  • Kidney Cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms