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

This study has been withdrawn prior to enrollment.
(Withdrawn due to no accrual)
Sponsor:
Collaborator:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00524069
First received: August 31, 2007
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Bevacizumab Based Peri-Operative Therapy for Operable Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Feasibility and safety [ Designated as safety issue: Yes ]
  • Margin status after pancreatic resection [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with positive resection margins, including microscopic (R1) or gross (R2) positive resection margins [ Designated as safety issue: No ]
  • Median survival [ Designated as safety issue: No ]
  • Time to recurrence [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Correlation of CEC number and VEGFR expression with margin positivity, survival, and recurrence [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: January 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.

  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

    • 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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524069

Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Renuka Iyer, MD Roswell Park Cancer Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00524069     History of Changes
Other Study ID Numbers: I 68805, RPCI-I-68805
Study First Received: August 31, 2007
Last Updated: January 31, 2013
Health Authority: United States: Federal Government

Keywords provided by Roswell Park Cancer Institute:
stage I pancreatic cancer
stage II pancreatic cancer
adenocarcinoma of the pancreas

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

ClinicalTrials.gov processed this record on September 30, 2014