Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
George Albert Fisher
With
Novartis
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
