Clinical trial NCT00425386 (phase 2, status: completed)
Conditions: kidney cancer
ICD codes: D17.71, D30.00, D30.01, D30.02, D41.00, D41.01, D41.02
Drugs: erlotinib hydrochloride, sunitinib malate
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2, CCN(CC)CCNC(=O)C1=C(C)NC(\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C
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