Full Text View
Tabular View
No Study Results Posted
Related Studies
Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer
This study has been completed.
Study NCT00028834   Information provided by National Cancer Institute (NCI)
First Received: January 4, 2002   Last Updated: February 6, 2009   History of Changes

January 4, 2002
February 6, 2009
February 2002
 
 
 
Complete list of historical versions of study NCT00028834 on ClinicalTrials.gov Archive Site
 
 
 
Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer
A Phase II Trial Of Bevacizumab (NSC#704865) Plus Gemcitabine In Patients With Advanced Pancreatic Cancer

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.

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.

Phase II
Interventional
Treatment, Open Label
Pancreatic Cancer
  • Biological: bevacizumab
  • Drug: gemcitabine hydrochloride
 
Kindler HL, Friberg G, Singh DA, Locker G, Nattam S, Kozloff M, Taber DA, Karrison T, Dachman A, Stadler WM, Vokes EE. Phase II trial of bevacizumab plus gemcitabine in patients with advanced pancreatic cancer. J Clin Oncol. 2005 Nov 1;23(31):8033-40.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00028834
 
CDR0000069138, UCCRC-11255B, NCI-2675
University of Chicago
National Cancer Institute (NCI)
Study Chair: Hedy L. Kindler, MD University of Chicago
National Cancer Institute (NCI)
October 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP