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Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00524069
Recruitment Status : Withdrawn (Withdrawn due to no accrual)
First Posted : September 3, 2007
Last Update Posted : February 1, 2013
National Cancer Institute (NCI)
Information provided by:
Roswell Park Cancer Institute

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor cells.

PURPOSE: This clinical trial is studying the side effects and how well giving gemcitabine and capecitabine together with bevacizumab works in treating patients with pancreatic cancer that can be removed by surgery.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: bevacizumab Drug: capecitabine Drug: gemcitabine hydrochloride Other: flow cytometry Other: laboratory biomarker analysis Procedure: adjuvant therapy Procedure: computed tomography Procedure: neoadjuvant therapy Not Applicable

Detailed Description:



  • To determine the feasibility and safety of bevacizumab-based neoadjuvant and adjuvant therapy in patients with resectable pancreatic adenocarcinoma.
  • To determine the proportion of patients with margin-positive resections after pancreatic resection.


  • To estimate overall survival of patients treated with this regimen.
  • To assess the time to recurrence in patients treated with this regimen.
  • To measure the change in the number of circulating endothelial precursor cells (CEC) and VEGF expression on CEC at baseline and after the start of neoadjuvant therapy and examine their relationship with response, time to recurrence, and survival.
  • To assess the utility of dynamic contrast-enhanced spiral CT scan as surrogate endpoints for antiangiogenic therapy.

OUTLINE: This is a multicenter study.

  • Neoadjuvant therapy: Patients receive gemcitabine IV over 30 minutes on days 1 and 8; oral capecitabine twice daily on days 1-14; and bevacizumab* IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients receive bevacizumab during courses 1 and 2 only.

  • Surgical resection: Within 6-8 weeks after the last dose of bevacizumab, patients undergo surgical resection of the pancreatic tumor.
  • Adjuvant therapy: Beginning 6-10 weeks after surgery, patients receive up to 6 additional courses of gemcitabine, capecitabine, and bevacizumab as in neoadjuvant therapy.

Patients undergo blood sample collection at baseline and periodically during study for biomarker correlative studies. Samples are analyzed by flow cytometry to measure levels of circulating endothelial precursor cells and VEGF markers of angiogenesis. Patients also undergo dynamic contrast-enhanced (DCE) spiral CT scan of the abdomen. DCE-CT imaging studies are performed at baseline and after completion of neoadjuvant therapy (1-2 weeks prior to surgical resection) to assess changes in tumor blood flow, blood volume, and tumor vasculature.

After completion of study therapy, patients are followed periodically for at least 5 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Bevacizumab Based Peri-Operative Therapy for Operable Pancreatic Adenocarcinoma
Study Start Date : January 2007
Actual Primary Completion Date : November 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Primary Outcome Measures :
  1. Feasibility and safety
  2. Margin status after pancreatic resection

Secondary Outcome Measures :
  1. Proportion of patients with positive resection margins, including microscopic (R1) or gross (R2) positive resection margins
  2. Median survival
  3. Time to recurrence
  4. Overall survival
  5. Number of circulating endothelial precursor cells (CEC) and their VEGFR expression as measured by flow cytometry at baseline and after the start of neoadjuvant therapy
  6. Correlation of CEC number and VEGFR expression with margin positivity, survival, and recurrence
  7. Changes in blood volume, blood flow, mean transit time, and color flow maps of the tumor as measured by dynamic contrast-enhanced spiral CT scan at baseline and after completion of neoadjuvant therapy
  8. Toxicity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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


  • Histologically or cytologically confirmed pancreatic adenocarcinoma

    • Resectable disease (i.e., stage I or II disease)

      • No unresectable (i.e., locally advanced) disease
  • No tumor invasion into the stomach or duodenum
  • No CNS, brain, or systemic metastases


  • ECOG performance status 0-1
  • WBC > 3,000/μL
  • ANC > 1,500/μL
  • Platelet count > 100,000/μL
  • Total bilirubin < 2 mg/dL
  • AST or ALT < 2.5 times upper limit of normal (ULN)
  • Creatinine < 1.5 mg/dL
  • Creatinine clearance ≥ 50 mL/min
  • Urine protein:creatinine ratio < 1.0
  • Hemoglobin ≥ 9 g/dL (transfusion, epoetin alfa, or darbepoetin allowed)
  • INR < 1.5 times ULN (except in patients receiving full-dose warfarin)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled hypertension
  • No unstable angina
  • No New York Heart Association class II-IV congestive heart failure
  • No myocardial infarction or stroke within the past 6 months
  • No clinically significant peripheral vascular disease
  • No evidence of bleeding diathesis or coagulopathy
  • No significant traumatic injury within the past 28 days
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • No esophageal or gastric varices
  • No serious nonhealing wound, ulcer, or bone fracture


  • No prior therapy for pancreatic cancer
  • More than 4 weeks since prior and no concurrent participation in another experimental drug study
  • More than 28 days since prior major surgical procedure or open biopsy
  • More than 7 days since prior minor surgical procedure (e.g., fine-needle aspiration or core biopsy)

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 identifier (NCT number): NCT00524069

Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
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Principal Investigator: Renuka Iyer, MD Roswell Park Cancer Institute
Layout table for additonal information Identifier: NCT00524069    
Other Study ID Numbers: I 68805
First Posted: September 3, 2007    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013
Keywords provided by Roswell Park Cancer Institute:
stage I pancreatic cancer
stage II pancreatic cancer
adenocarcinoma of the pancreas
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors