ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Combination Chemotherapy for 1st Line Treatment of Advanced or Metastatic Pancreatic Cancer

This study has been completed.

Sponsors and Collaborators: University of Oklahoma
Genentech
Sanofi-Aventis
M.D. Anderson Cancer Center
Information provided by: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00222469
  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.


Condition Intervention Phase
Metastatic Pancreatic Cancer
Drug: bevacizumab
Drug: gemcitabine
Drug: oxaliplatin
Phase II

MedlinePlus related topics:   Cancer    Pancreatic Cancer   

ChemIDplus related topics:   Gemcitabine hydrochloride    Gemcitabine    Bevacizumab    Oxaliplatin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase II Trial of Bevacizumab Plus Gemcitabine™ and Oxaliplatin™ as First Line Therapy in Metastatic or Locally Advanced (Unresectable) Pancreatic Cancer

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To determine the tolerability and toxicity profile of this regimen in this patient population [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Enrollment:   50
Study Start Date:   August 2005
Study Completion Date:   May 2007
Primary Completion Date:   May 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
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.

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.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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
Sanofi-Aventis
M.D. Anderson Cancer Center

Investigators
Principal Investigator:     Mehrdad Jafari, MD, PhD     University of Oklahoma    
  More Information


Responsible Party:   University of Oklahoma Dept. of Medicine ( Mehrdad Jafari, MD )
Study ID Numbers:   2004-0652
First Received:   September 20, 2005
Last Updated:   July 8, 2008
ClinicalTrials.gov Identifier:   NCT00222469
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Oxaliplatin
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Bevacizumab
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on October 03, 2008




Links to all studies - primarily for crawlers