Sunitinib and Gemcitabine in Treating Patients With Pancreatic Cancer or Other Solid Tumors

Criteria:

• Histologically or cytologically confirmed pancreatic adenocarcinoma OR other solid tumor:
• Not amenable to curative therapy
• Previously untreated metastatic pancreatic adenocarcinoma allowed
• Measurable or evaluable disease
• No history of or known brain metastases, spinal cord compression, carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening CT scan or MRI scan
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Life expectancy >= 12 weeks
• Absolute neutrophil count >= 1,500/mm3
• Platelet count >= 100,000/mm3
• Hemoglobin >= 8.5 g/dL
• Bilirubin =< 1.5 mg/dL
• Creatinine normal OR creatinine clearance >= 60 mL/min
• AST and ALT =< 2.5 times upper limit of normal (ULN) (=< 5 times ULN if due to underlying disease)
• Calcium =< 12.0 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 6 months after completion of study therapy
• LVEF normal by MUGA scan or ECHO at baseline
• Deep venous thrombosis or pulmonary embolism allowed provided they are clinically stable and adequately treated
• No preexisting thyroid abnormality that results in the inability to maintain thyroid function in the normal range while using medication
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate
• No history of any of the following within the past 6 months:
• Myocardial infarction
• Ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation >= 3 beats in a row)
• Severe/unstable angina
• Severe peripheral vascular disease (i.e., claudication)
• Procedure on peripheral vasculature
• Coronary/peripheral artery bypass graft
• Cerebrovascular accident
• No history of any of the following within the past 6 months:
• Transient ischemic attack;
• Clinically significant bleeding requiring red blood cell transfusion
• No NYHA class III or IV heart disease:
• Patients with NYHA class II disease who are stable and on medication are eligible
• No ongoing cardiac dysrhythmias >= grade 2, atrial fibrillation of any grade, or any significant EKG abnormalities
• No hypertension that cannot be controlled by medications to a systolic blood pressure (BP) of < 140 mm Hg and diastolic BP of < 90 mm Hg
• No condition that impairs the ability to swallow and retain sunitinib malate tablets, including any of the following:
• Gastrointestinal tract disease resulting in an inability to take oral medication
• Requirement for IV alimentation
• Prior surgical procedures affecting absorption
• Active peptic ulcer disease
• No gastrointestinal perforation or intra-abdominal abscess within the past 28 days
• No serious nonhealing infection or bone fracture
• No other severe acute or chronic medical condition, psychiatric condition, or laboratory abnormality that would preclude study therapy
• May have received any number of prior systemic therapies
• More than 4 weeks since prior radiotherapy or surgery and recovered
• More than 4 weeks since other prior therapies and recovered
• Prior gemcitabine hydrochloride allowed
• No prior sunitinib malate or other therapy directed against VEGF, including any of the following:

Sorafenib; Bevacizumab; Vatalanib; AZD2171; VEGF Trap; Investigational antiangiogenic therapy

• More than 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
• Ketoconazole
• Itraconazole
• Clarithromycin
• Erythromycin
• Diltiazem
• Verapamil
• Indinavir
• Ritonavir
• Nelfinavir
• Saquinavir
• Atazanavir
• Delavirdine
• More than 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:
• Rifampin
• Rifabutin
• Carbamazepine
• Phenobarbital
• Phenytoin
• Hypericum perforatum (St. John's wort)
• Efavirenz
• Tipranavir
• No concurrent agents with proarrhythmic potential, including any of the following:
• Terfenadine
• Quinidine
• Procainamide
• Disopyramide
• Sotalol
• Probucol
• Bepridil
• Haloperidol
• Risperidone
• Indapamide
• Flecainide
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent treatment on another clinical trial:

Participation in non-therapeutic clinical trials allowed

• QTc < 500 msec