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

NCT ID: NCT01264341

Last Updated: 2017-02-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2015-07-31

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

Conditions

Kidney Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab combined with temsirolimus

Bevacizumab 10mg/kg intravenous every 2 weeks Temsirolimus 25mg intravenous once weekly

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

Bevacizumab 10mg/kg intravenous every 2 weeks until disease progression, unacceptable toxicity or consent withdrawal.

Temsirolimus

Intervention Type: DRUG

Temsirolimus 25mg intravenous once weekly until disease progression, unacceptable toxicity or consent withdrawal.

Interventions

Bevacizumab

Bevacizumab 10mg/kg intravenous every 2 weeks until disease progression, unacceptable toxicity or consent withdrawal.

Intervention Type: DRUG

Temsirolimus

Temsirolimus 25mg intravenous once weekly until disease progression, unacceptable toxicity or consent withdrawal.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hellenic Cooperative Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aristotelis Bamias, MD, PhD

Role: STUDY_CHAIR

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

Locations

General Peripheral Hospital of Athens "Alexandra"

Athens, Athens, Greece

General Hospital of Athens "Hippokratio"

Athens, , Greece

Agii Anargiri Cancer Hospital, 2nd Dept of Medical Oncology

Athens, , Greece

Agii Anargiri Cancer Hospital, 3rd Dept of Medical Oncology

Athens, , Greece

Metropolitan Hospital, 1st Dept of Medical Oncology

Athens, , Greece

Metropolitan Hospital, 2nd Dept of Medical Oncology

Athens, , Greece

University Hospital of Patras

Rio, Patras, , Greece

Papageorgiou General Hospital

Thessaloniki, , Greece

Countries

Greece

References

Bamias A, Karavasilis V, Gavalas N, Tzannis K, Samantas E, Aravantinos G, Koutras A, Gkerzelis I, Kostouros E, Koutsoukos K, Zagouri F, Fountzilas G, Dimopoulos MA. The combination of bevacizumab/temsirolimus after first-line anti-VEGF therapy in advanced renal-cell carcinoma: a clinical and biomarker study. Int J Clin Oncol. 2019 Apr;24(4):411-419. doi: 10.1007/s10147-018-1361-9. Epub 2018 Oct 29.

Reference Type: DERIVED

PMID: 30374686 (View on PubMed)

Other Identifiers

2010-020664-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HE 21/10

Identifier Type: -

Identifier Source: org_study_id