Phase 1-2 Vatalanib and Gemcitabine in Advanced Pancreatic Cancer

Inclusion Criteria

* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* Unresectable (due to involvement of critical vasculature, adjacent organ invasion, or presence of metastasis)
* If \> 5 years between the primary surgery and the development of metastatic disease, then separate histological or cytological confirmation of metastatic disease
* Primary or metastatic lesion within 4 weeks prior to entry of study
* WHO performance status of 0 to 2
* ≤ 18 years of age
* Absolute Neutrophil Count (ANC) ≥ 1.5 x 10e9/L (\>= 1500/mm3)
* Platelets (PLT) ≥ 100 x 10\^9/L (≥ 100,000/mm3)
* Hemoglobin (Hgb) ≥ 9 g/dL
* Serum creatinine ≤ 1.5 upper limit of normal (ULN)
* Serum bilirubin ≤ 1.5 ULN
* Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase

  * (ALT/SGPT) ≤ 3.0 x ULN OR
  * ≤ 5 x ULN if liver metastases present
* Proteinuria:

  * Negative for proteinuria based on dip stick reading OR
  * If dip stick reading is +1 result, then total urinary protein ≤ 500 mg and measured creatinine clearance (CrCl) ≥ 50 mL/min from a 24-hour urine collection
* Life expectancy ≥ 12 weeks
* Ability to give written informed consent

Exclusion Criteria

* For the "phase 1" portion of the study: prior gemcitabine will be therapy.
* For the "phase 2" portion of the study: any prior chemotherapy {except for low-dose 5-fluorouracil (5-FU)as a radiosensitizer\]
* Radiotherapy (RT). The site of previous RT must have progressive disease if the only site of disease).

  * Prior full field radiotherapy ≤ 4 weeks prior to enrollment OR
  * Limited field radiotherapy ≤ 2 weeks prior to enrollment. Patients must have recovered from all therapy-related toxicities.
* Prior biologic or immunotherapy ≤ 2 weeks prior to registration.
* Prior therapy with anti-VEGF agents
* History or presence of central nervous system (CNS) disease
* Patients with a history of another primary malignancy ≤ 5 years (Exception: inactive basal or squamous cell carcinoma of the skin)
* Major surgery ≤ 4 weeks prior to enrollment. (Exception: insertion of a vascular access device)
* Minor surgery ≤ 2 weeks prior to enrollment. (Exception: insertion of a vascular access device)
* Concurrent use of other investigational agents and patients who have received investigational drugs ≤ 4 weeks prior to enrollment.
* Pregnant, or breast-feeding, not employing an effective method of birth control.
* Pre-existing peripheral sensory neuropathy with functional impairment (≥ CTCAE grade 2 neuropathy)
* Respiratory compromise due to pleural effusion or ascites (≥ CTCAE grade 2 dyspnea)
* QTc \> 450 ms (male) or \> 470 ms (female)
* Uncontrolled high blood pressure
* History of labile hypertension
* History of poor compliance with an antihypertensive regimen
* Unstable angina pectoris
* Symptomatic congestive heart failure
* Myocardial infarction ≤ 6 months prior to registration / randomization
* Serious uncontrolled cardiac arrhythmia
* Uncontrolled diabetes
* Active or uncontrolled infection
* Interstitial pneumonia
* Extensive and symptomatic interstitial fibrosis of the lung
* Chronic renal disease
* Acute or chronic liver disease
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib
* Human immunodeficiency virus (HIV) infection (confirmed), if there is potential for interaction between vatalanib and any anti-HIV medication
* HIV infection (confirmed) judged to increase subject risk due to the pharmacologic activity of vatalanib
* Receiving warfarin sodium (Coumadin) or similar. Heparin is allowed.
* Unwilling to or unable to comply with