Sunitinib and Erlotinib in Treating Patients With Unresectable or Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: erlotinib hydrochloride; sunitinib malate; biopsy
Intervention description: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;
100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
150 mg/day, continuous daily; Will be administered at 50 mg daily, 4 weeks on, 2 weeks off; Paraffin block (or unstained slides) of the primary tumor and/or metastatic lesions (as available) and a plasma sample for future correlative studies will be collected. A paraffin block (or at least 10 unstained slides, each of 10 micromillimeter thickness) from the original paraffin-embedded biopsy material taken at the diagnosis will be stored at 4 degrees Celsius.
Intervention MeSH terms: Erlotinib Hydrochloride; Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage III renal cell cancer; stage IV renal cell cancer; clear cell renal cell carcinoma; recurrent renal cell cancer

Summary:

      RATIONALE: Sunitinib and erlotinib may stop the growth of tumor cell by blocking some of the
      enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib
      together with erlotinib may kill more tumor cells.

      PURPOSE: This phase II trial is studying the best dose of erlotinib when given together with
      sunitinib and to see how well they work in treating patients with unresectable or metastatic
      kidney cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed renal cell carcinoma with a component of clear cell or
             papillary carcinoma

               -  Unresectable or metastatic disease (radiologically or clinically confirmed)

          -  Measurable disease (≥ 1 site)

          -  No known brain metastasis that has not been adequately treated with radiotherapy
             and/or surgery

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  No grade 3 hemorrhage within the past 4 weeks

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 times ULN (<
             5 times ULN if due to underlying disease)

          -  No chronic liver disease (i.e., chronic active hepatitis or cirrhosis)

          -  Creatinine ≤ 1.5 times ULN

          -  None of the following cardiovascular conditions within the past 12 months:

               -  Myocardial infarction

               -  Severe/unstable angina

               -  Coronary/peripheral artery bypass graft

               -  Symptomatic congestive heart failure

               -  Cerebrovascular accident or transient ischemic attack

               -  Pulmonary embolism

               -  Ongoing cardiac dysrhythmia ≥ grade 2

               -  Atrial fibrillation of any grade

               -  Prolongation of the corrected QT (QTc) interval to > 450 msec for males or to >
                  470 msec for females

          -  Left Ventricular Ejection Fraction (LVEF) normal by Multigated Acquisition (MUGA) or
             echocardiogram

          -  No hypertension uncontrolled with medical therapy

          -  No other active malignancy within the past 5 years except basal cell skin cancer or
             cervical carcinoma in situ

          -  No uncontrolled adrenal insufficiency

          -  No uncontrolled hypothyroidism

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

          -  No severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic
             renal disease, or active uncontrolled infection)

          -  No impaired gastrointestinal (GI) function or GI disease that may significantly alter
             the absorption of study drugs

          -  No other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that would preclude study participation

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  More than 4 weeks since prior major surgery

          -  More than 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or
             mitomycin C)

          -  More than 4 weeks since prior radiotherapy

          -  No prior radiotherapy to > 25% of the bone marrow

          -  More than 28 days since prior investigational agents

          -  No prior sunitinib malate

          -  No prior anti-epidermal growth factor receptor therapy (e.g., erlotinib hydrochloride,
             panitumumab, cetuximab, or gefitinib)

          -  No concurrent therapeutic warfarin

               -  Low-dose oral warfarin ≤ 2 mg daily for deep vein thrombosis prophylaxis is
                  allowed after the maximum tolerated dose of erlotinib hydrochloride is determined

          -  No concurrent Hypericum perforatum (St. John's wort)

          -  No concurrent chemotherapy or biologic therapy

          -  No other concurrent anticancer therapy

          -  No other concurrent investigational agents