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Combination Chemotherapy for 1st Line Treatment of Advanced or Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00222469
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : July 9, 2008
Sponsor:
Collaborators:
Genentech, Inc.
Sanofi
M.D. Anderson Cancer Center
Information provided by:
University of Oklahoma

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.


Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: bevacizumab Drug: gemcitabine Drug: oxaliplatin Phase 2

Detailed Description:

Design:

  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II Trial of Bevacizumab Plus Gemcitabine™ and Oxaliplatin™ as First Line Therapy in Metastatic or Locally Advanced (Unresectable) Pancreatic Cancer
Study Start Date : August 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
3-agent treatment group
Drug: bevacizumab
10mg/kg IV on Day 1 Q 2 weeks

Drug: gemcitabine
1000mg/m2 as fixed-rate infusion at 10mg/m2/min on Day 1 and Q 2 weeks.

Drug: oxaliplatin
100mg/m2 on Day 2 and Q 2 weeks.




Primary Outcome Measures :
  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 [ Time Frame: One year ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: One year ]
  2. To determine the tolerability and toxicity profile of this regimen in this patient population [ Time Frame: One year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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 requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222469


Locations
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
University of Oklahoma
Genentech, Inc.
Sanofi
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Mehrdad Jafari, MD, PhD University of Oklahoma

Responsible Party: Mehrdad Jafari, MD, University of Oklahoma Dept. of Medicine
ClinicalTrials.gov Identifier: NCT00222469     History of Changes
Other Study ID Numbers: 2004-0652
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: July 9, 2008
Last Verified: July 2008

Keywords provided by University of Oklahoma:
pancreatic cancer
unresectable pancreatic cancer
metastatic pancreatic cancer
bevacizumab
oxaliplatin
gemcitabine
1st line treatment
first line treatment
locally advanced (unresectable) pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Oxaliplatin
Bevacizumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors