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

NCT01264341 | Terminated Phase 2

• 2 other identifiers: HE 21/102010-020664-38
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 8

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

Outcome Measures

Primary Outcomes (1)

• 6-month Progression Free Survival (PFS)

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

  32 months

Secondary Outcomes (7)

• Progression Free Survival (PFS)

  Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks

• Overall Survival (OS)

  48 months

• Response Rate (RR)

  Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks

• Tumor Shrinkage

  Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks

• Adverse Events (AEs) of all participants will be recorded and assessed upon signature of the informed consent form, until 30 days after the last administration of study treatment.

  3 years

Study Arms (1)

Bevacizumab combined with temsirolimus

EXPERIMENTAL

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

Drug: Bevacizumab; Drug: Temsirolimus

Interventions

Bevacizumab DRUG

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

Bevacizumab combined with temsirolimus

Temsirolimus DRUG

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

Bevacizumab combined with temsirolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Study Sites (8)

General Peripheral Hospital of Athens "Alexandra"

Athens, Athens, 11528, Greece

Location

General Hospital of Athens "Hippokratio"

Athens, 11527, Greece

Location

Agii Anargiri Cancer Hospital, 2nd Dept of Medical Oncology

Athens, 14564, Greece

Location

Agii Anargiri Cancer Hospital, 3rd Dept of Medical Oncology

Athens, 14564, Greece

Location

Metropolitan Hospital, 1st Dept of Medical Oncology

Athens, 18547, Greece

Location

Metropolitan Hospital, 2nd Dept of Medical Oncology

Athens, 18547, Greece

Location

University Hospital of Patras

Rio, Patras, 26500, Greece

Location

Papageorgiou General Hospital

Thessaloniki, 56429, Greece

Location

Related Publications (1)

• 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.

  PMID: 30374686 DERIVED

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Bevacizumab; temsirolimus

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Aristotelis Bamias, MD, PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 21, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 14, 2017

Record last verified: 2017-02

Locations

GR (8)