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A Phase II Trial of Bevacizumab Plus Gemcitabine™ and Oxaliplatin™ as First Line Therapy in Metastatic or Locally Advanced (Unresectable) Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Metastatic Pancreatic Cancer

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Trial Information

A Phase II Trial of Bevacizumab Plus Gemcitabine™ and Oxaliplatin™ as First Line Therapy in Metastatic or Locally Advanced (Unresectable) Pancreatic Cancer


- A phase II single arm study. All patients receive bevacizumab 10mg/kg and gemcitabine
1000mg/m2 on day 1 followed by oxaliplatin 100mg/m2 on day 2 of a 14 day cycle.


- The purpose of this study is to find out if giving patients bevacizumab, along with the
chemotherapy drugs oxaliplatin and gemcitabine, will improve overall survival. In
addition, the study will find out what side effects patients may have by taking
bevacizumab, oxaliplatin and gemcitabine together.


- Approximately 30 patients will be enrolled to the study between the University of
Oklahoma and M.D. Anderson Cancer Center.


- The study will be conducted over approximately 2 years.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
brain metastases.

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To determine the overall survival (OS) rate at 1 year in this patient population, treated with the combination therapy of bevacizumab plus gemcitabine and oxaliplatin

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Mehrdad Jafari, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Oklahoma


United States: Food and Drug Administration

Study ID:




Start Date:

August 2005

Completion Date:

May 2007

Related Keywords:

  • Metastatic Pancreatic Cancer
  • pancreatic cancer
  • unresectable pancreatic cancer
  • metastatic pancreatic cancer
  • bevacizumab
  • oxaliplatin
  • gemcitabine
  • 1st line treatment
  • first line treatment
  • locally advanced (unresectable) pancreatic cancer
  • Pancreatic Neoplasms



MD Anderson Cancer Center Houston, Texas  77030-4096
University of Oklahoma Oklahoma City, Oklahoma  73190