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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Hellenic Cooperative Oncology Group
Sponsor:
Information provided by (Responsible Party):
Hellenic Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT01264341
First received: December 20, 2010
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Kidney Cancer
Drug: Bevacizumab
Drug: Temsirolimus
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hellenic Cooperative Oncology Group:

Primary Outcome Measures:
  • 6-month Progression Free Survival (PFS) [ Time Frame: 32 months ] [ Designated as safety issue: No ]
    Proportion of patients who are progression-free at 6month evaluation from treatment initiation


Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks ] [ Designated as safety issue: No ]
    PFS will be calculated from date of treatment initiation until disease progression or death (whichever occurs first)

  • Overall Survival (OS) [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    OS will be calculated from the date of treatment initiation to the date of death or last contact

  • Response Rate (RR) [ Time Frame: Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks ] [ Designated as safety issue: No ]
    RR is defined as the overall percentage of patients with partial (PR) or complete response (CR). The evaluation of responses will be performed according to RECIST criteria

  • Tumor Shrinkage [ Time Frame: Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks ] [ Designated as safety issue: No ]
    Tumor shrinkage will be computed using waterfall plots

  • 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. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Adverse Events will be graded according to the NCI CTCAE v3.0 criteria and will be reported in a frequency table according to the highest severity grade observed per patient

  • Quality of Life (QoL) assessment [ Time Frame: At baseline and every 8 weeks during treatment ] [ Designated as safety issue: No ]
    QoL will be assessed using the EORTC QLQ C-30 questionnaire. The change in the QoL during treatment will be estimated using the Wilcoxon paired t-test

  • Investigation of antiangiogenic factors (FGF, VEGF, VEGFRR) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Changes in serum levels of antiangiogenic factors during treatment and correlation to the outcome of study treatment.


Estimated Enrollment: 47
Study Start Date: December 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab combined with temsirolimus
Bevacizumab 10mg/kg intravenous every 2 weeks Temsirolimus 25mg intravenous once weekly
Drug: Bevacizumab
Bevacizumab 10mg/kg intravenous every 2 weeks until disease progression, unacceptable toxicity or consent withdrawal.
Drug: Temsirolimus
Temsirolimus 25mg intravenous once weekly until disease progression, unacceptable toxicity or consent withdrawal.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264341

Locations
Greece
General Hospital of Athens "Hippokratio" Not yet recruiting
Athens, Greece, 11527
Contact: Dimitrios Pectasides, MD       pectasid@otenet.gr   
Principal Investigator: Dimitrios Pectasides, MD         
Metropolitan Hospital, 1st Dept of Medical Oncology Recruiting
Athens, Greece, 18547
Contact: Dimitrios Bafaloukos, MD       dimmp@otenet.gr   
Principal Investigator: Dimitrios Bafaloukos, MD         
Metropolitan Hospital, 2nd Dept of Medical Oncology Recruiting
Athens, Greece, 18547
Contact: Eleni Galani, MD       eleni_galani@yahoo.gr   
Principal Investigator: Eleni Galani, MD         
General Peripheral Hospital of Athens "Alexandra" Recruiting
Athens, Greece, 11528
Contact: Aristotelis Bamias, MD       abamias@med.uoa.gr   
Principal Investigator: Aristotelis Bamias, MD         
Agii Anargiri Cancer Hospital, 2nd Dept of Medical Oncology Recruiting
Athens, Greece, 14564
Contact: Gerassimos Aravantinos, MD    0030 210 3501278    bpstudies@yahoo.gr   
Principal Investigator: Gerassimos Aravantinos, MD         
Agii Anargiri Cancer Hospital, 3rd Dept of Medical Oncology Recruiting
Athens, Greece, 14564
Contact: Anastasios Visvikis, MD       hecogaga@otenet.gr   
Principal Investigator: Anastasios Visvikis, MD         
University Hospital of Patras Recruiting
Rio, Patras, Greece, 26500
Contact: Angelos Koutras, MD       angkoutr@otenet.gr   
Principal Investigator: Angelos Koutras, MD         
Papageorgiou General Hospital Recruiting
Thessaloniki, Greece, 56429
Contact: George Fountzilas, MD       fountzil@auth.gr   
Principal Investigator: George Fountzilas, MD         
Sponsors and Collaborators
Hellenic Cooperative Oncology Group
Investigators
Study Chair: Aristotelis Bamias, MD, PhD General Peripheral Hospital of Athens "Alexandra", Medical School, University of Athens
  More Information

No publications provided

Responsible Party: Hellenic Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT01264341     History of Changes
Other Study ID Numbers: HE 21/10, 2010-020664-38
Study First Received: December 20, 2010
Last Updated: December 20, 2013
Health Authority: Greece:National Organization for Medicines
Greece:National Ethics Committee

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Bevacizumab
Sirolimus
Everolimus
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on October 19, 2014