A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: combination of gemcitabine, capecitabine, and bevacizumab
Intervention description: gemcitabine 1000 mg/m^2 d1, 8, capecitabine 1000 mg (flat dose) po bid d1-14, and bevacizumab 15 mg/kg d 1, on a 21 day cycle
Intervention MeSH terms: Bevacizumab; Gemcitabine; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic; renal cell; kidney; neoplasm

Summary:

      The purpose of this study is to find out what effects (good and bad) the combination of the
      chemotherapy drugs gemcitabine, capecitabine, and bevacizumab has on a patient and kidney
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed metastatic clear cell renal cell cancer

          -  Measurable disease

          -  Age 18 or older

          -  ECOG performance status of 0 - 1

          -  Blood pressure less than 140/90 on 2 separate occasions not more than 6 weeks prior to
             enrollment and not less than 24 hours apart

          -  Normal organ function

          -  Women of child-bearing potential and men must agree to use adequate contraception

          -  Ability to understand and the willingness to sign a written informed consent document
             and to follow all required study procedures

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering
             the study or those who have not recovered from adverse events due to agents
             administered more than 4 weeks earlier

          -  Patients may not have had prior treatment with pyrimidine analogs or VEGF binding
             agents

          -  Patients may not be receiving any other investigational or therapeutic agents

          -  Patients may not be receiving therapeutic anticoagulation with warfarin, its
             congeners, heparin, low molecular weight heparinoids, specific thrombin inhibitors, or
             other similar agents Patients receiving low dose coumadin (1 mg daily) for central
             line patency are eligible

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to treatment start, or anticipation of need for major surgical procedure during
             the course of the study Fine needle aspirations or core biopsies within 7 days prior
             to treatment start are acceptable

          -  Serious, nonhealing wound, ulcer, or bone fracture

          -  Evidence of bleeding diathesis or coagulopathy

          -  Patients with known brain metastases

          -  Uncontrolled intercurrent illness

          -  Pregnant women

          -  HIV-positive patients receiving combination anti-retroviral therapy are excluded from
             the study