A Phase II Trial of Bevacizumab Plus Gemcitabine™ and Oxaliplatin™ as First Line Therapy in Metastatic or Locally Advanced (Unresectable) Pancreatic Cancer
- Age >/= 18 years old
- ECOG performance status 0-2.
- Patients with metastatic or unresectable locally advanced adenocarcinoma of the
- Patients who have recurrent disease post pancreaticoduodenectomy no earlier than 6
months after resection. Patients with recurrent disease who had completed adjuvant
therapy in the form of radiation with or without radiosensitizing 5-fluorouracil
(5-FU) 6 months prior to recurrence may be included.
- Signed informed consent/authorization is obtained prior to conducting any study
specific screening procedures.
- No prior chemotherapy for advanced pancreatic cancer
- Patient must have measurable disease
- Use of effective means of contraception (men and women) in subjects of child-bearing
- Obstructive jaundice must be relieved before inclusion
- Adequate hepatic, renal, and bone marrow function: leukocytes >= 3,000/uL, absolute
neutrophil count >= 1,500/uL, platelets >= 100,000/uL, total bilirubin < = 1.5 X
institutional upper limits of normal (ULN), AST (SGOT)/ALT (SGPT) <= 2.5 X
institutional ULN, creatinine <= 1.5 mg/dL
- Previous chemotherapy for pancreatic cancer.
- Patients who have recurrent disease within 6 months after pancreaticoduodenectomy or
had received adjuvant therapy within 6 months of disease recurrence.
- Uncontrolled intercurrent illness including:
- Active infection
- Cardiovascular: New York Heart Association (NYHA) grade II or greater congestive
heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled
with medication, myocardial infarction within the previous 6 months, blood
pressure > 150/100 mmHg
- Clinically significant peripheral vascular disease
- History of stroke within previous 6 months
- Evidence of bleeding diathesis or coagulopathy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0, anticipation of need for major surgical procedure during the course
of the study.
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days
prior to Day 0
- Urine protein:creatinine ratio > 1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 28 days prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
- Patients with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive
neurological dysfunction that would confound the evaluation of neurological and other
adverse events. A computed tomography (CT) scan of the brain is not needed for
eligibility and will be done only if the patient presents with symptoms suggestive of
- Patients may not be receiving any other investigational agents, or have participated
in any investigational drug study within 28 days preceding start of study treatment.
- The teratogenic potential of this combination is currently unknown. Women who are
pregnant or lactating are excluded.
- History of any other malignancy in the last 5 years, except patients with a prior
history of in situ cancer or basal or squamous cell skin cancer.
- Peripheral neuropathy > grade 1
- Psychiatric illness/social situations that would limit compliance with study