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Bevacizumab, Erlotinib, and Imatinib in the Treatment of Advanced Renal Cell Carcinoma

Primary Purpose

Clear Cell Renal Cell Carcinoma

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Bevacizumab
Erlotinib
Imatinib
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clear Cell Renal Cell Carcinoma focused on measuring Recurrent clear cell renal cell carcinoma, Bevacizumab, Erlotinib, Imatinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: To be included in this study, you must meet the following criteria: Metastatic or unresectable clear cell renal carcinoma confirmed by biopsy Previous nephrectomy is required Maximum of 1 previous systemic regimen for metastatic disease. Able to perform activities of daily living with minimal assistance Measurable disease Adequate bone marrow, liver and kidney Written informed consent. Exclusion Criteria: Age < 18 years Treatment with more than 1 previous systemic regimen History of heart attack within 6 months Clinically significant cardiovascular disease Moderate to severe vascular disease. Active brain metastases. History or evidence by physical examination of brain tumor Seizures not controlled with standard medical therapy history of stroke or other serious disorders of the nervous system Clinical history of coughing or vomiting blood within the past 3 months. PEG tubes or G tubes Chronic therapy with NSAIDS or other platelet inhibitors Proteinuria Nonhealing wound, ulcer, or long bone fracture Clinical evidence or history of a bleeding disorder Requiring full dose anticoagulation with coumadin Receiving chronic steroid therapy Significant medical conditions. Tumors other than clear cell History of stroke within 6 months. History of abdominal fistula,perforation,or abscess within 6 months. Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily

    Outcomes

    Primary Outcome Measures

    Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
    Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
    Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

    Secondary Outcome Measures

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    January 24, 2013
    Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Genentech, Inc., Novartis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00193258
    Brief Title
    Bevacizumab, Erlotinib, and Imatinib in the Treatment of Advanced Renal Cell Carcinoma
    Official Title
    A Phase I/II Trial of Bevacizumab (Avastin), Erlotinib (Tarceva), and Imatinib (Gleevec) in the Treatment of Patients With Advanced Renal Cell Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2004 (undefined)
    Primary Completion Date
    January 2011 (Actual)
    Study Completion Date
    August 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Genentech, Inc., Novartis

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This phase I/II trial will evaluate the bevacizumab/erlotinib combination with the addition of imatinib (Gleevec). The combined inhibition greatly enhances the anti-tumor effects. Although the safety of the bevacizumab/erlotinib/imatinib combination has not yet been demonstrated, the mild to moderate side effects of all of these agents are not predicted to cause prohibitive toxicity. A brief phase I portion will be included in this trial, to optimize doses of the 3 agents prior to proceeding with the phase II trial.
    Detailed Description
    Upon determination of eligibility, patients will be receive: Bevacizumab + Erlotinib + Imatinib A brief phase I dose escalation study will be performed to define the imatinib dose that will be used.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Clear Cell Renal Cell Carcinoma
    Keywords
    Recurrent clear cell renal cell carcinoma, Bevacizumab, Erlotinib, Imatinib

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    94 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
    Intervention Type
    Drug
    Intervention Name(s)
    Bevacizumab
    Other Intervention Name(s)
    Avastin
    Intervention Description
    10mg/kg IV infusion every 2 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Erlotinib
    Other Intervention Name(s)
    Tarceva
    Intervention Description
    150 mg po daily
    Intervention Type
    Drug
    Intervention Name(s)
    Imatinib
    Other Intervention Name(s)
    STI571, Gleevec, Glivec, imatinib mesilate (INN)
    Intervention Description
    400-600mg daily
    Primary Outcome Measure Information:
    Title
    Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
    Description
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
    Time Frame
    18 months
    Title
    Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
    Time Frame
    18 months
    Title
    Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: To be included in this study, you must meet the following criteria: Metastatic or unresectable clear cell renal carcinoma confirmed by biopsy Previous nephrectomy is required Maximum of 1 previous systemic regimen for metastatic disease. Able to perform activities of daily living with minimal assistance Measurable disease Adequate bone marrow, liver and kidney Written informed consent. Exclusion Criteria: Age < 18 years Treatment with more than 1 previous systemic regimen History of heart attack within 6 months Clinically significant cardiovascular disease Moderate to severe vascular disease. Active brain metastases. History or evidence by physical examination of brain tumor Seizures not controlled with standard medical therapy history of stroke or other serious disorders of the nervous system Clinical history of coughing or vomiting blood within the past 3 months. PEG tubes or G tubes Chronic therapy with NSAIDS or other platelet inhibitors Proteinuria Nonhealing wound, ulcer, or long bone fracture Clinical evidence or history of a bleeding disorder Requiring full dose anticoagulation with coumadin Receiving chronic steroid therapy Significant medical conditions. Tumors other than clear cell History of stroke within 6 months. History of abdominal fistula,perforation,or abscess within 6 months. Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John D. Hainsworth, MD
    Organizational Affiliation
    SCRI Development Innovations, LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18272024
    Citation
    Hainsworth JD, Spigel DR, Sosman JA, Burris HA 3rd, Farley C, Cucullu H, Yost K, Hart LL, Sylvester L, Waterhouse DM, Greco FA. Treatment of advanced renal cell carcinoma with the combination bevacizumab/erlotinib/imatinib: a phase I/II trial. Clin Genitourin Cancer. 2007 Dec;5(7):427-32. doi: 10.3816/CGC.2007.n.030.
    Results Reference
    result
    Links:
    URL
    http://cigjournals.metapress.com/content/78747811327l1q78/?p=add93b1605a842cb946ca178813c9b17&pi=2
    Description
    Published article in Clinical Genitourinary Cancer

    Learn more about this trial

    Bevacizumab, Erlotinib, and Imatinib in the Treatment of Advanced Renal Cell Carcinoma

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