Efficacy and Safety of Bevacizumab/Temsirolimus Combination to Treat Advanced Renal Cell Carcinoma

Hellenic Cooperative Oncology Group

Status and phase

Terminated

Phase 2

Conditions

Kidney Cancer

Treatments

Drug: Temsirolimus

Drug: Bevacizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT01264341

HE 21/10

2010-020664-38 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.