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