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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.
 
ClinicalTrials.gov Identifier: NCT00524069
Recruitment Status : Withdrawn (Withdrawn due to no accrual)
First Posted : September 3, 2007
Last Update Posted : February 1, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Roswell Park Cancer Institute

Tracking Information
First Submitted Date  ICMJE August 31, 2007
First Posted Date  ICMJE September 3, 2007
Last Update Posted Date February 1, 2013
Study Start Date  ICMJE January 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2007)
  • Feasibility and safety
  • Margin status after pancreatic resection
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2007)
  • Proportion of patients with positive resection margins, including microscopic (R1) or gross (R2) positive resection margins
  • Median survival
  • Time to recurrence
  • Overall survival
  • 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
  • Correlation of CEC number and VEGFR expression with margin positivity, survival, and recurrence
  • 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
  • Toxicity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery
Official Title  ICMJE A Pilot Study of Bevacizumab Based Peri-Operative Therapy for Operable Pancreatic Adenocarcinoma
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.

Detailed Description

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Biological: bevacizumab
  • Drug: capecitabine
  • Drug: gemcitabine hydrochloride
  • Other: flow cytometry
  • Other: laboratory biomarker analysis
  • Procedure: adjuvant therapy
  • Procedure: computed tomography
  • Procedure: neoadjuvant therapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 31, 2013)
0
Original Enrollment  ICMJE
 (submitted: August 31, 2007)
30
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00524069
Other Study ID Numbers  ICMJE I 68805
RPCI-I-68805
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Renuka Iyer, MD Roswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date January 2013

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