Cediranib Maleate in Treating Patients With Recurrent or Metastatic Kidney Cancer That Cannot Be Removed By Surgery
Condition: Recurrent Renal Cell Carcinoma; Stage IV Renal Cell Cancer
MeSH terms: Carcinoma; Carcinoma, Renal Cell; Recurrence
Intervention: Cediranib Maleate; Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Laboratory Biomarker Analysis; Pharmacological Study
Intervention description: Given PO; Correlative studies; Correlative studies; Correlative studies
Intervention MeSH terms: Cediranib; Maleic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well cediranib maleate works in treating patients with
      recurrent or metastatic kidney cancer that cannot be removed by surgery. Cediranib maleate
      may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed renal cell cancer that is
             locally recurrent or metastatic and is not considered curable by standard therapy

          -  Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >
             20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT)
             scan; bone lesions are not considered to be measurable; all radiology must be
             performed within 28 days prior to registration

          -  Previous therapy:

               -  Surgery: Previous surgery is permissible; patients must be >= 4 weeks since any
                  major surgery

               -  Chemotherapy: No previous systemic chemotherapy

               -  Immunotherapy: No previous therapy permitted

               -  Gene/investigational therapy: No prior therapy is permitted

               -  Radiation: Patients may have had radiation therapy but must have recovered from
                  acute toxic effects prior to registration; at least 4 weeks must have elapsed
                  since last dose of radiation before registration (exceptions may be made for
                  low-dose, non-myelosuppressive radiotherapy); if the sole site of measurable
                  disease is in a radiation field, there must have been documented progression at
                  that site for patient to be eligible

          -  Life expectancy of greater than 3 months

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

          -  Absolute neutrophil count >= 1.5 x10^9/L

          -  Platelets >= 100 x10^9/L

          -  Total bilirubin =< 1.5 x upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 3 × institutional ULN

          -  Creatinine =< 1.5 x ULN OR creatinine clearance >= 60 mL/min/1.73 m^2

          -  AZD2171 has been shown to terminate fetal development in the rat, as expected for a
             process dependent on vascular endothelial growth factor (VEGF) signaling; for this
             reason, women of child-bearing potential must have a negative pregnancy test prior to
             study entry; women of child-bearing potential and men must agree to use adequate
             contraception (hormonal or barrier method of birth control; abstinence) prior to study
             entry and for the duration of study participation; should a woman become pregnant or
             suspect she is pregnant while participating in this study, she should inform her
             treating physician immediately

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients who have had radiotherapy, or major surgery within 4 weeks prior to entering
             the study or those who have not recovered from adverse events of these therapies

          -  Patients may not be receiving any other investigational agents nor have participated
             in an investigational trial

          -  Patients with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to AZD2171

          -  Mean corrected QT interval (QTc) > 470 msec (with Bazett's correction) in screening
             electrocardiogram or history of familial long QT syndrome

          -  Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week
             apart

          -  Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing
             or active infection, symptomatic congestive heart failure, unstable angina pectoris,
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements

          -  Pregnant women are excluded from this study because AZD2171 is a VEGF inhibitor with
             known abortifacient effects; because there is an unknown but potential risk for
             adverse events in nursing infants secondary to treatment of the mother with AZD2171,
             breastfeeding should be discontinued if the mother is treated with AZD2171

          -  Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
             therapy are ineligible because of the potential for pharmacokinetic interactions with
             AZD2171; appropriate studies will be undertaken in patients receiving combination
             antiretroviral therapy when indicated

          -  Any significant abnormality noted in the electrocardiogram (ECG) within 14 days of
             treatment

          -  A New York Heart Association classification of III or IV (NOTE: Patients classified as
             class II controlled with treatment may continue with increase monitoring)

          -  Conditions requiring concurrent use of drugs or biologics with proarrhythmic
             potential; these drugs are prohibited during studies with AZD2171