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Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer

This study has been completed.

Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028834
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with a monoclonal antibody may kill more tumor cells.

PURPOSE: This phase II trial is to see if combining gemcitabine with bevacizumab works in treating patients who have advanced pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Drug: bevacizumab
Drug: gemcitabine hydrochloride
Phase II

MedlinePlus related topics:   Cancer    Pancreatic Cancer   

Drug Information available for:   Gemcitabine hydrochloride    Gemcitabine    Bevacizumab    Pancrelipase    Ultrase   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase II Trial Of Bevacizumab (NSC#704865) Plus Gemcitabine In Patients With Advanced Pancreatic Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   February 2002

Detailed Description:

OBJECTIVES:

  • Determine the objective response rate of patients with advanced pancreatic cancer treated with bevacizumab and gemcitabine.
  • Determine the toxicity of this regimen in these patients.
  • Determine the median and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 8-10 months.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed pancreatic adenocarcinoma

    • Not amenable to curative treatment with surgery or radiotherapy
    • Locally advanced disease must extend outside the boundaries of a standard radiation port
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
    • Pleural effusions and ascites not considered measurable lesions
  • No obvious tumor involvement of major vessels on CT scan
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 3 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No prior bleeding diathesis

Hepatic:

  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper limit of normal
  • PT INR no greater than 1.5

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min
  • Urine protein less than 500 mg/24 hours if at least 1+ proteinuria
  • No significant renal impairment

Cardiovascular:

  • No prior cardiovascular accident
  • No prior deep vein thrombosis
  • No myocardial ischemia or infarction within the past 6 months
  • No uncompensated coronary artery disease within the past 6 months
  • No uncontrolled hypertension
  • No symptomatic congestive heart failure
  • No cardiac arrhythmia
  • No clinically significant peripheral artery disease
  • No arterial thromboembolic event within the past 6 months, including any of the following:

    • Transient ischemic attack
    • Cerebrovascular accident
    • Unstable angina
    • Myocardial infarction

Pulmonary:

  • No prior pulmonary embolism

Other:

  • No concurrent uncontrolled illness
  • No ongoing or active infection
  • No other concurrent active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No psychiatric illness or social situation that would preclude study entry
  • No prior allergic reaction attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents (Chinese hamster ovary cell products or other recombinant human antibodies) used in this study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior bevacizumab

Chemotherapy:

  • No prior cytotoxic chemotherapy for metastatic disease
  • No prior gemcitabine
  • At least 4 weeks since prior adjuvant chemotherapy and recovered

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to sole site of measurable disease

Surgery:

  • See Disease Characteristics
  • At least 6 weeks since prior major surgery

Other:

  • At least 30 days since prior investigational agents
  • At least 1 month since prior and no concurrent thrombolytic agents or full-dose anticoagulants (except to maintain patency of pre-existing permanent indwelling IV catheters)
  • No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer therapy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028834

Locations
United States, Arizona
Mayo Clinic Scottsdale    
      Scottsdale, Arizona, United States, 85259
United States, California
City of Hope Comprehensive Cancer Center    
      Duarte, California, United States, 91010-3000
City of Hope Medical Group    
      Pasadena, California, United States, 91105
University of California Davis Cancer Center    
      Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital    
      Los Angeles, California, United States, 90033
United States, District of Columbia
Howard University Cancer Center    
      Washington, District of Columbia, United States, 20060
United States, Florida
Mayo Clinic    
      Jacksonville, Florida, United States, 32224
United States, Illinois
Decatur Memorial Hospital Cancer Care Institute    
      Decatur, Illinois, United States, 62526
Evanston Northwestern Health Care - Evanston Hospital    
      Evanston, Illinois, United States, 60201-1781
Ingalls Memorial Hospital    
      Harvey, Illinois, United States, 60426
LaGrange Memorial Hospital    
      LaGrange, Illinois, United States, 60525
Oncology/Hematology Associates of Central Illinois, P.C.    
      Peoria, Illinois, United States, 61602
University of Chicago Cancer Research Center    
      Chicago, Illinois, United States, 60637-1470
United States, Indiana
CCOP - Northern Indiana CR Consortium    
      South Bend, Indiana, United States, 46601
Fort Wayne Medical Oncology and Hematology, Incorporated    
      Fort Wayne, Indiana, United States, 46885-5099
Memorial Hospital of South Bend    
      South Bend, Indiana, United States, 46617
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins    
      Baltimore, Maryland, United States, 21231
United States, Michigan
Barbara Ann Karmanos Cancer Institute    
      Detroit, Michigan, United States, 48201
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph    
      Saint Joseph, Michigan, United States, 49085
United States, Minnesota
Mayo Clinic Cancer Center    
      Rochester, Minnesota, United States, 55905
United States, Missouri
Siteman Cancer Center    
      Saint Louis, Missouri, United States, 63110
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute    
      Pittsburgh, Pennsylvania, United States, 15232
United States, Wisconsin
Medical College of Wisconsin Cancer Center    
      Milwaukee, Wisconsin, United States, 53226
University of Wisconsin Comprehensive Cancer Center    
      Madison, Wisconsin, United States, 53792-3236

Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)

Investigators
Study Chair:     Hedy L. Kindler, MD     University of Chicago    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000069138, UCCRC-11255B, NCI-2675
First Received:   January 4, 2002
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00028834
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III pancreatic cancer  
recurrent pancreatic cancer  
adenocarcinoma of the pancreas  
stage IV pancreatic cancer  

Study placed in the following topic categories:
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Bevacizumab
Pancrelipase
Recurrence
Digestive System Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
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 November 20, 2008




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