Sunitinib and Erlotinib in Treating Patients With Unresectable or Metastatic Kidney Cancer

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