Combination Chemotherapy for 1st Line Treatment of Advanced or Metastatic Pancreatic Cancer
NCT ID: NCT00222469
Last Updated: 2008-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2005-08-31
2007-05-31
Brief Summary
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In addition, the study will find out what side effects patients may have by taking bevacizumab, oxaliplatin, and gemcitabine together.
Detailed Description
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* 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.
Purpose:
* 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.
Enrollment:
* Approximately 30 patients will be enrolled to the study between the University of Oklahoma and M.D. Anderson Cancer Center.
Duration:
* The study will be conducted over approximately 2 years.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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1
3-agent treatment group
bevacizumab
10mg/kg IV on Day 1 Q 2 weeks
gemcitabine
1000mg/m2 as fixed-rate infusion at 10mg/m2/min on Day 1 and Q 2 weeks.
oxaliplatin
100mg/m2 on Day 2 and Q 2 weeks.
Interventions
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bevacizumab
10mg/kg IV on Day 1 Q 2 weeks
gemcitabine
1000mg/m2 as fixed-rate infusion at 10mg/m2/min on Day 1 and Q 2 weeks.
oxaliplatin
100mg/m2 on Day 2 and Q 2 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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 requirements
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Sanofi
INDUSTRY
M.D. Anderson Cancer Center
OTHER
University of Oklahoma
OTHER
Responsible Party
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University of Oklahoma Dept. of Medicine
Principal Investigators
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Mehrdad Jafari, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma
Locations
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University of Oklahoma
Oklahoma City, Oklahoma, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Other Identifiers
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2004-0652
Identifier Type: -
Identifier Source: org_study_id