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

December 20, 2010
December 20, 2013
December 2010
April 2014   (final data collection date for primary outcome measure)
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
6-month Progression Free Survival (PFS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Proportion of patients who are progression-free at 6month evaluation from treatment initiation
Complete list of historical versions of study NCT01264341 on ClinicalTrials.gov Archive Site
  • 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.
  • 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: 42 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.
Not Provided
Not Provided
 
Efficacy and Safety of Bevacizumab/Temsirolimus Combination to Treat Advanced Renal Cell Carcinoma
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

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Cancer
  • 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.
Experimental: Bevacizumab combined with temsirolimus
Bevacizumab 10mg/kg intravenous every 2 weeks Temsirolimus 25mg intravenous once weekly
Interventions:
  • Drug: Bevacizumab
  • Drug: Temsirolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
47
October 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Greece
 
NCT01264341
HE 21/10, 2010-020664-38
No
Hellenic Cooperative Oncology Group
Hellenic Cooperative Oncology Group
Not Provided
Study Chair: Aristotelis Bamias, MD, PhD General Peripheral Hospital of Athens "Alexandra", Medical School, University of Athens
Hellenic Cooperative Oncology Group
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP