Combination Chemotherapy for 1st Line Treatment of Advanced or Metastatic Pancreatic Cancer
A Phase II Trial of Bevacizumab Plus Gemcitabine™ and Oxaliplatin™ as First Line Therapy in Metastatic or Locally Advanced (Unresectable) Pancreatic Cancer
1 other identifier
interventional
50
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2005
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 20, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedJuly 9, 2008
July 1, 2008
1.7 years
September 20, 2005
July 8, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
One year
Secondary Outcomes (2)
To determine the objective tumor response rate in this patient population. To determine time to progression (TTP) and progression free survival (PFS) in this patient population
One year
To determine the tolerability and toxicity profile of this regimen in this patient population
One year
Study Arms (1)
1
EXPERIMENTAL3-agent treatment group
Interventions
Eligibility Criteria
You may qualify if:
- Age \>/= 18 years old
- ECOG performance status 0-2.
- Patients with metastatic or unresectable locally advanced adenocarcinoma of the pancreas.
- 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 potential
- 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
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oklahomalead
- Genentech, Inc.collaborator
- Sanoficollaborator
- M.D. Anderson Cancer Centercollaborator
Study Sites (2)
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mehrdad Jafari, MD, PhD
University of Oklahoma
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 20, 2005
First Posted
September 22, 2005
Study Start
August 1, 2005
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
July 9, 2008
Record last verified: 2008-07