<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01684397</url>
  </required_header>
  <id_info>
    <org_study_id>I 191711</org_study_id>
    <secondary_id>NCI-2012-01247</secondary_id>
    <secondary_id>13-069</secondary_id>
    <secondary_id>I 191711</secondary_id>
    <nct_id>NCT01684397</nct_id>
  </id_info>
  <brief_title>Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer</brief_title>
  <official_title>A Phase I/II Trial of Pazopanib Alternating With Bevacizumab in Treatment-Naive Metastatic Clear Cell Renal Cell Carcinoma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roswell Park Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Roswell Park Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase I/II trial studies the side effects and best dose of pazopanib hydrochloride and&#xD;
      bevacizumab and to see how well they work in treating patients with previously untreated&#xD;
      kidney cancer that has spread to other places in the body (metastatic). Pazopanib&#xD;
      hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for&#xD;
      cell growth. Pazopanib hydrochloride may also stop the growth of tumor cells by blocking&#xD;
      blood flow to the tumor. Monoclonal antibodies, such as bevacizumab, can prevent tumor growth&#xD;
      by blocking the ability of tumor cells to grow and spread. Giving pazopanib hydrochloride&#xD;
      together with bevacizumab may kill more tumor cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
        -  I. To determine the safe phase II dose of this novel regimen. (Phase I)&#xD;
&#xD;
        -  II. To determine the median progression free survival (PFS) from this novel regimen.&#xD;
           (Phase II)&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the safety and toxicity of the proposed regimen. (Phase I) II. To evaluate the&#xD;
      response rate. (Phase I) III. To evaluate the pharmacokinetics of pazopanib (pazopanib&#xD;
      hydrochloride). (Phase I) IV. To evaluate the vascular endothelial growth factor (VEGF)&#xD;
      levels and myeloid derived suppressor cell (MDSC) levels at various time points and correlate&#xD;
      with response. (Phase I) V. To evaluate the safety and toxicity of this new regimen. (Phase&#xD;
      II) VI. To evaluate the VEGF levels, interleukin (IL)-8 levels and MDSC levels at various&#xD;
      time points and correlate with outcome. (Phase II) VII. To evaluate the PFS rate at 12&#xD;
      months. (Phase II) VIII. To evaluate overall survival. (Phase II)&#xD;
&#xD;
      OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.&#xD;
&#xD;
      Patients receive pazopanib hydrochloride orally (PO) on days 1-28, and bevacizumab&#xD;
      intravenously (IV) over 30-90 minutes on days 36 and 50. Courses repeat every 70 days in the&#xD;
      absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 30 days and Phase II&#xD;
      patients are followed up by telephone every 12 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 21, 2012</start_date>
  <completion_date type="Anticipated">November 21, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 21, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Median PFS (Phase II)</measure>
    <time_frame>Up to 30 days post-treatment</time_frame>
    <description>Distributions of continuous variables will be summarized with commonly used statistics (mean, standard deviation, median, etc.), with sub-group associations tested using the Wilcoxon Rank Sum test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Optimal phase II dose, defined as the largest dose level at which less than 2 out of the 6 patients experienced dose-limiting toxicity, graded according to Common Terminology Criteria for Adverse Events version 4.0 (Phase I)</measure>
    <time_frame>Up to 140 days</time_frame>
    <description>The frequency of toxicities will be tabulated for the dose estimated to be the maximum-tolerated dose.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of grade 3 or higher toxicities, graded according to CTCAE version 4.0</measure>
    <time_frame>Up to 30 days post-treatment</time_frame>
    <description>Categorical variables will be summarized in contingency tables, with associations of interest assessed using Fisher's exact test. The frequency of toxicities will be tabulated by grade across all dose levels and courses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (Phase II)</measure>
    <time_frame>From the date of study enrollment to the date of death from any cause, assessed up to 30 days post-treatment</time_frame>
    <description>Will be obtained using Kaplan-Meier and Proportional Hazards methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS rate at 12 months (Phase II)</measure>
    <time_frame>At 12 months</time_frame>
    <description>Distributions of continuous variables will be summarized with commonly used statistics (mean, standard deviation, median, etc.), with sub-group associations tested using the Wilcoxon Rank Sum test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate according to RECIST 1.1 (Phase I)</measure>
    <time_frame>Up to 30 days post-treatment</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>IL-8 levels</measure>
    <time_frame>Up to 30 days post-treatment</time_frame>
    <description>Distributions of continuous variables will be summarized with commonly used statistics (mean, standard deviation, median, etc.), with sub-group associations tested using the Wilcoxon Rank Sum test.</description>
  </other_outcome>
  <other_outcome>
    <measure>MDSC levels</measure>
    <time_frame>Up to 30 days post-treatment</time_frame>
    <description>Distributions of continuous variables will be summarized with commonly used statistics (mean, standard deviation, median, etc.), with sub-group associations tested using the Wilcoxon Rank Sum test.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pazopanib exposure as measured by pharmacokinetics parameters</measure>
    <time_frame>Course 1 on day 1 at pre-dose, 2 hours, and 4 hours post-dose; day 15 at pre-dose and 2 hours post-dose; and day 29</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>VEGF levels</measure>
    <time_frame>Up to 30 days post-treatment</time_frame>
    <description>Distributions of continuous variables will be summarized with commonly used statistics (mean, standard deviation, median, etc.), with sub-group associations tested using the Wilcoxon Rank Sum test.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">51</enrollment>
  <condition>Clear Cell Renal Cell Carcinoma</condition>
  <condition>Stage IV Renal Cell Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment (pazopanib hydrochloride and bevacizumab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive pazopanib hydrochloride PO on days 1-28 and bevacizumab IV over 30-90 minutes on days 36 and 50. Courses repeat every 70 days in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (pazopanib hydrochloride and bevacizumab)</arm_group_label>
    <other_name>Anti-VEGF</other_name>
    <other_name>Anti-VEGF Humanized Monoclonal Antibody</other_name>
    <other_name>Anti-VEGF rhuMAb</other_name>
    <other_name>Avastin</other_name>
    <other_name>Bevacizumab Biosimilar BEVZ92</other_name>
    <other_name>Bevacizumab Biosimilar BI 695502</other_name>
    <other_name>Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer</other_name>
    <other_name>Recombinant Humanized Anti-VEGF Monoclonal Antibody</other_name>
    <other_name>rhuMab-VEGF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (pazopanib hydrochloride and bevacizumab)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pazopanib Hydrochloride</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (pazopanib hydrochloride and bevacizumab)</arm_group_label>
    <other_name>GW786034B</other_name>
    <other_name>Votrient</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pharmacological Study</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (pazopanib hydrochloride and bevacizumab)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Biopsy/pathology-proven clear cell renal cell carcinoma (CCRCC) with metastases&#xD;
&#xD;
          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status =&lt; 1&#xD;
&#xD;
          -  Hemoglobin &gt;= 10 gm/dL&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;= 1.5 x 10^9/L&#xD;
&#xD;
          -  Platelets &gt;= 100 x 10^9/L&#xD;
&#xD;
          -  Total bilirubin =&lt; upper limit of normal (ULN)&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =&lt; ULN&#xD;
&#xD;
          -  International normalization ratio (INR) and activated partial thromboplastin time&#xD;
             (aPTT) &lt; 1.2 x ULN&#xD;
&#xD;
          -  Serum creatinine &lt; 1.5 mg/dL or if serum creatinine &gt; 1.5 mg/dL then calculate&#xD;
             creatinine clearance (CrCL) &gt; 30 mL/min&#xD;
&#xD;
          -  Urine protein to creatinine ratio =&lt; 1 (if urine protein creatinine ratio is &gt; 1, then&#xD;
             a 24-hour urine total protein must be assessed; subjects will be ineligible if the&#xD;
             24-hour urine protein is found to be &gt; 1 gm)&#xD;
&#xD;
          -  Normal cardiac ejection fraction (&gt; 50%) by multi gated acquisition scan (MUGA) or&#xD;
             echocardiogram&#xD;
&#xD;
          -  Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1&#xD;
             criteria present&#xD;
&#xD;
          -  Ability to swallow and retain oral medication&#xD;
&#xD;
          -  Subjects of child-bearing potential must agree to use adequate contraceptive methods&#xD;
             (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry&#xD;
             and for the duration of study participation; should a woman become pregnant or suspect&#xD;
             she is pregnant while she or her partner is participating in this study, she should&#xD;
             inform her treating physician immediately&#xD;
&#xD;
          -  Subject or legal representative must understand the investigational nature of this&#xD;
             study and sign an Independent Ethics Committee/Institutional Review Board approved&#xD;
             written informed consent form prior to receiving any study related procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with known brain metastases should be excluded from this clinical trial&#xD;
&#xD;
          -  Prior VEGF targeted therapies for renal cell carcinoma (RCC) including adjuvant or&#xD;
             neoadjuvant treatments; in phase 1 only, one prior therapy with high dose IL-2 or&#xD;
             anti-programmed cell death (PD)-1 compound alone or in combination with cytotoxic&#xD;
             T-lymphocyte-associated protein 4 (CTLA-4) targeting drug is allowed on the trial&#xD;
&#xD;
          -  Subjects diagnosed with another cancer in the past 3 years; excluding basal cell&#xD;
             carcinoma or squamous cell carcinoma, of skin which were completely cured by resection&#xD;
&#xD;
          -  Concurrent use of another anti-cancer drug including an investigational anti-cancer&#xD;
             agent&#xD;
&#xD;
          -  Major surgery within 28 days prior to treatment or major surgery planned during the&#xD;
             next 6 months&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic or psychiatric illness/social situations that would limit&#xD;
             compliance with study requirements&#xD;
&#xD;
          -  History of any of the following cardio-vascular condition:&#xD;
&#xD;
               -  Myocardial infarction (MI)&#xD;
&#xD;
               -  Unstable angina&#xD;
&#xD;
               -  Coronary artery bypass grafting (CABG)-unless patient had a negative stress test&#xD;
                  within 6 months of screening&#xD;
&#xD;
               -  Coronary angioplasty or stenting&#xD;
&#xD;
               -  Symptomatic peripheral arterial disease (PAD)&#xD;
&#xD;
               -  History of symptomatic chronic congestive heart failure (CHF)&#xD;
&#xD;
               -  History of cerebrovascular accidents including transient ischemic attacks (TIA)&#xD;
&#xD;
               -  Corrected QT interval (QTc) &gt; 480 msec&#xD;
&#xD;
               -  Uncontrolled hypertension (systolic blood pressure [BP] &gt; 150 mm Hg or diastolic&#xD;
                  BP of &gt; 90 mm Hg); if the screening BP is elevated, adjustments in&#xD;
                  anti-hypertensives are permitted and a re-screening will be permitted for BP&#xD;
                  assessment with three consecutive values obtained 2 minutes apart; the 3 values&#xD;
                  have to be below 150/90 mm Hg for eligibility and can only be obtained after 2&#xD;
                  days of the last change in anti-hypertensive medication; use of clonidine is not&#xD;
                  permissible for adjusting the BP during this period&#xD;
&#xD;
          -  History of deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past 6 months&#xD;
&#xD;
          -  Subjects should not have packed red blood cells (PRBC) or platelet transfusion within&#xD;
             14 days of the screening&#xD;
&#xD;
          -  Evidence of active bleeding or bleeding disorder&#xD;
&#xD;
          -  Subjects currently on anti-coagulation therapy are not eligible&#xD;
&#xD;
          -  Unable to discontinue the use of prohibited medications&#xD;
&#xD;
          -  Pregnant or nursing female subjects&#xD;
&#xD;
          -  Unwilling or unable to follow protocol requirements&#xD;
&#xD;
          -  Any condition which in the investigator's opinion deems the subject an unsuitable&#xD;
             candidate to receive study drug&#xD;
&#xD;
          -  Received an investigational agent within 30 days prior to enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saby George</last_name>
    <role>Principal Investigator</role>
    <affiliation>Roswell Park Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Kansas Cancer Center</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jane Ledesma</last_name>
      <phone>913-588-0545</phone>
      <email>jledesma2@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Rahul Parikh, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Karamanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>482018</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ulka Vaishampayan, MD</last_name>
      <phone>313-576-8715</phone>
      <email>vaishamu@karmanos.org</email>
    </contact>
    <investigator>
      <last_name>Ulka Vaishamu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roswell Park</last_name>
      <phone>877-275-7724</phone>
      <email>ASKRPCI@roswellpark.org</email>
    </contact>
    <investigator>
      <last_name>Saby George</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Cancer Institute (UPCI)</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rahul A. Parikh</last_name>
      <phone>412-692-4724</phone>
      <email>parikhr@upmc.edu</email>
    </contact>
    <investigator>
      <last_name>Rahul A. Parikh</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Deepak Kilari, MD</last_name>
      <phone>414-805-3666</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Antineoplastic Agents, Immunological</mesh_term>
    <mesh_term>Endothelial Growth Factors</mesh_term>
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
    <mesh_term>Immunoglobulin G</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01684397
org study id: I 191711
secondary id: NCI-2012-01247
secondary id: 13-069
secondary id: I 191711
nct id: NCT01684397
lead sponsor: 
collaborator: 
has dmc: Yes
This phase I/II trial studies the side effects and best dose of pazopanib hydrochloride and
      bevacizumab and to see how well they work in treating patients with previously untreated
      kidney cancer that has spread to other places in the body (metastatic). Pazopanib
      hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for
      cell growth. Pazopanib hydrochloride may also stop the growth of tumor cells by blocking
      blood flow to the tumor. Monoclonal antibodies, such as bevacizumab, can prevent tumor growth
      by blocking the ability of tumor cells to grow and spread. Giving pazopanib hydrochloride
      together with bevacizumab may kill more tumor cells.
PRIMARY OBJECTIVES:

        -  I. To determine the safe phase II dose of this novel regimen. (Phase I)

        -  II. To determine the median progression free survival (PFS) from this novel regimen.
           (Phase II)

      SECONDARY OBJECTIVES:

      I. To evaluate the safety and toxicity of the proposed regimen. (Phase I) II. To evaluate the
      response rate. (Phase I) III. To evaluate the pharmacokinetics of pazopanib (pazopanib
      hydrochloride). (Phase I) IV. To evaluate the vascular endothelial growth factor (VEGF)
      levels and myeloid derived suppressor cell (MDSC) levels at various time points and correlate
      with response. (Phase I) V. To evaluate the safety and toxicity of this new regimen. (Phase
      II) VI. To evaluate the VEGF levels, interleukin (IL)-8 levels and MDSC levels at various
      time points and correlate with outcome. (Phase II) VII. To evaluate the PFS rate at 12
      months. (Phase II) VIII. To evaluate overall survival. (Phase II)

      OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

      Patients receive pazopanib hydrochloride orally (PO) on days 1-28, and bevacizumab
      intravenously (IV) over 30-90 minutes on days 36 and 50. Courses repeat every 70 days in the
      absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up at 30 days and Phase II
      patients are followed up by telephone every 12 months
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Median PFS (Phase II)
time frame: Up to 30 days post-treatment
description: Distributions of continuous variables will be summarized with commonly used statistics (mean, standard deviation, median, etc.), with sub-group associations tested using the Wilcoxon Rank Sum test.
measure: Optimal phase II dose, defined as the largest dose level at which less than 2 out of the 6 patients experienced dose-limiting toxicity, graded according to Common Terminology Criteria for Adverse Events version 4.0 (Phase I)
time frame: Up to 140 days
description: The frequency of toxicities will be tabulated for the dose estimated to be the maximum-tolerated dose.
measure: Incidence of grade 3 or higher toxicities, graded according to CTCAE version 4.0
time frame: Up to 30 days post-treatment
description: Categorical variables will be summarized in contingency tables, with associations of interest assessed using Fisher's exact test. The frequency of toxicities will be tabulated by grade across all dose levels and courses.
measure: Overall survival (Phase II)
time frame: From the date of study enrollment to the date of death from any cause, assessed up to 30 days post-treatment
description: Will be obtained using Kaplan-Meier and Proportional Hazards methods.
measure: PFS rate at 12 months (Phase II)
time frame: At 12 months
description: Distributions of continuous variables will be summarized with commonly used statistics (mean, standard deviation, median, etc.), with sub-group associations tested using the Wilcoxon Rank Sum test.
measure: Response rate according to RECIST 1.1 (Phase I)
time frame: Up to 30 days post-treatment
measure: IL-8 levels
time frame: Up to 30 days post-treatment
description: Distributions of continuous variables will be summarized with commonly used statistics (mean, standard deviation, median, etc.), with sub-group associations tested using the Wilcoxon Rank Sum test.
measure: MDSC levels
time frame: Up to 30 days post-treatment
description: Distributions of continuous variables will be summarized with commonly used statistics (mean, standard deviation, median, etc.), with sub-group associations tested using the Wilcoxon Rank Sum test.
measure: Pazopanib exposure as measured by pharmacokinetics parameters
time frame: Course 1 on day 1 at pre-dose, 2 hours, and 4 hours post-dose; day 15 at pre-dose and 2 hours post-dose; and day 29
measure: VEGF levels
time frame: Up to 30 days post-treatment
description: Distributions of continuous variables will be summarized with commonly used statistics (mean, standard deviation, median, etc.), with sub-group associations tested using the Wilcoxon Rank Sum test.
arm group label: Treatment (pazopanib hydrochloride and bevacizumab)
arm group type: Experimental
description: Patients receive pazopanib hydrochloride PO on days 1-28 and bevacizumab IV over 30-90 minutes on days 36 and 50. Courses repeat every 70 days in the absence of disease progression or unacceptable toxicity.
intervention type: Biological
intervention name: Bevacizumab
description: Given IV
arm group label: Treatment (pazopanib hydrochloride and bevacizumab)
other name: Anti-VEGF
other name: Anti-VEGF Humanized Monoclonal Antibody
other name: Anti-VEGF rhuMAb
other name: Avastin
other name: Bevacizumab Biosimilar BEVZ92
other name: Bevacizumab Biosimilar BI 695502
other name: Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
other name: Recombinant Humanized Anti-VEGF Monoclonal Antibody
other name: rhuMab-VEGF
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Treatment (pazopanib hydrochloride and bevacizumab)
intervention type: Drug
intervention name: Pazopanib Hydrochloride
description: Given PO
arm group label: Treatment (pazopanib hydrochloride and bevacizumab)
other name: GW786034B
other name: Votrient
intervention type: Other
intervention name: Pharmacological Study
description: Correlative studies
arm group label: Treatment (pazopanib hydrochloride and bevacizumab)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Saby George
role: Principal Investigator
affiliation: Roswell Park Cancer Institute
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Bevacizumab
mesh term: Antineoplastic Agents, Immunological
mesh term: Endothelial Growth Factors
mesh term: Antibodies
mesh term: Immunoglobulins
mesh term: Antibodies, Monoclonal
mesh term: Immunoglobulin G