Ziv-Aflibercept in Treating Patients With Metastatic or Unresectable Kidney Cancer
Condition: Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: VEGF Trap
Intervention description: Given IV
Intervention MeSH terms: Aflibercept; Endothelial Growth Factors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Renal Cell Carcinoma; VEGF Trap

Summary:

      This randomized phase II trial studies how well ziv-aflibercept (VEGF Trap) works in treating
      patients with kidney cancer that has spread from the primary site to other places in the body
      (metastatic) or is unable to be removed with surgery (unresectable). Ziv-aflibercept may stop
      the growth of kidney cancer by blocking blood flow to the tumor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed metastatic or unresectable renal cell carcinoma; disease must
             be conventional clear cell carcinoma or have a component of clear cell carcinoma

          -  Patient must have measurable lesions according to the Response Evaluation Criteria In
             Solid Tumors (RECIST); baseline measurements must be performed =< 4 weeks prior to
             randomization

          -  Patient must have evidence of progressive disease following treatment with a tyrosine
             kinase inhibitor (TKI) as assessed by the site investigator on the basis of computed
             tomography (CT) scans and other appropriate clinical documentation

          -  Patient must have received at least one prior treatment with a VEGF receptor tyrosine
             kinase inhibitor for at least 12 weeks; prior treatment with either temsirolimus or
             everolimus is allowed; prior immunotherapy is limited to cytokine therapy with
             interleukin 2 and interferon alpha only

          -  Previous radiotherapy (RT) is permissible provided the measurable disease is outside
             the RT port; RT must be completed >= 3 weeks prior to randomization

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Patient must have recovered from any toxic effects of prior radiotherapy or surgical
             procedures within 4 weeks prior to randomization

          -  Adequate organ function as defined in the protocol

          -  For women of childbearing potential, a negative serum pregnancy test is required
             within 1 week prior to randomization

          -  Women of childbearing potential and sexually active males must agree to use an
             accepted and effective method of contraception while on this study, and for 6 months
             after the completion of the study; if a woman becomes pregnant while she is on this
             study or within 6 months after the last dose of protocol therapy, she must inform her
             treating physician immediately; if a man impregnates a woman while he is on this study
             or within 6 months after the last dose of protocol therapy, he must inform his
             treating physician immediately

          -  Patients who have had basal cell skin cancer, squamous cell skin cancer, in situ
             cervical cancer, ductal carcinoma in situ of the breast, or lobular carcinoma in situ
             of the breast within the past five years are eligible only if treated with curative
             intent; patients with other malignancies are eligible only if they have been
             continuously disease-free for > 5 years prior to the time of randomization

        Exclusion Criteria:

          -  True papillary, sarcomatoid features without any clear cell component, chromophobe,
             oncocytoma, collecting duct tumors and transitional cell carcinoma are not eligible

          -  Prior immunotherapy other than cytokine therapy with interleukin 2 and interferon
             alpha

          -  Prior treatment with bevacizumab

          -  Prior cellular therapy, vaccine, hormonal or chemotherapy for renal cell carcinoma;
             prior therapy for other cancers is allowable if therapy ended at least 5 years prior
             to enrollment

          -  History of metastatic central nervous system (CNS) disease

          -  Pregnant or breastfeeding

          -  Myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery
             bypass graft, New York Heart Association (NYHA) class III or IV congestive heart
             failure, cerebrovascular accident or transient ischemic attack within 24 weeks prior
             to randomization

          -  Prior pulmonary embolism, deep vein thrombosis, or other thromboembolic event

          -  History of uncontrolled or labile hypertension, with or without antihypertensive drug
             treatment, within 12 weeks prior to drug administration; this is defined as blood
             pressure > 150/100 mm Hg or systolic blood pressure > 180 mm Hg on at least 2 repeated
             determinations on separate days

          -  Active infection, evidence of bleeding or intratumoral bleeding, or underlying
             bleeding disorder

          -  History of hypersensitivity to any Trap agents or recombinant proteins

          -  Human immunodeficiency virus (HIV)-positive patients receiving combination
             anti-retroviral therapy