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Study of Combined RHUMAB VEGF and Capecitabine-Based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer

This study has been suspended.

Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00047710
  Purpose

The goal of this clinical research study is to find the highest safe dose of the drug Bevacizumab that can be given in combination with chemoradiation for the treatment of pancreatic cancer. The effect that this combination treatment has on the tumor will also be studied.


Condition Intervention Phase
Pancreatic Cancer
Drug: Bevacizumab
Phase I

MedlinePlus related topics:   Cancer    Pancreatic Cancer   

ChemIDplus related topics:   Capecitabine    Bevacizumab    Pancrelipase    Ultrase   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   A Phase I Trial of Concurrent RHUMAB VEGF (BEVACIZUMAB) and Capecitabine-Based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • The primary objective is to evaluate the safety of a combination of rhuMAb VEGF (BEVACIZUMAB) and capecitabine-based (chemo)radiotherapy in poor prognosis pancreatic cancer.

Secondary Outcome Measures:
  • To evaluate the local tumor response and median survival in patients treated with the above regimen.
  • To evaluate VEGF serum levels before and after anti-VEGF therapy.
  • To evaluate tumor hypoxia via PET scanning (gallium PET with the novel hypoxia tracer Ga-68 ECMN) before, during, and after therapy.
  • To evaluate quality of life in patients receiving this therapy.

Estimated Enrollment:   48
Study Start Date:   September 2002
Estimated Study Completion Date:   November 2004

Detailed Description:

This study administers 50.4 Gy of radiation for unresectable pancreatic cancer with concurrent capecitabine and an experimental drug, Bevacizumab. The drug is an antiangiogenic agent (kills tumor blood vessels) and has been shown in preclinical models to enhance the antitumor effect of radiation and chemotherapy.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion:

  • Cytology or histologic proof of adenocarcinoma of the pancreatic head, body or tail prior to treatment.
  • Patients with nonmetastatic, unresectable, disease are eligible.
  • Patients with regional nodal disease are eligible.
  • Karnofsky performance status >/=70.
  • No upper age restriction.
  • Absolute granulocyte count >1,500 cells/mm3 and platelet count at least 100,000 cells/mm3.
  • Serum bilirubin less than 5mg/dl prior to the start of therapy with adequate biliary decompression.
  • Adequate bilateral renal function.
  • Serum creatinine <1.5 mg/dl.
  • Adequate liver function; Alanine aminotransferase (ALT)/aspartate aminotransferase (AST)</=5 times upper limit of normal.
  • Sexually active men must practice contraception during study.
  • Patients must sign study-specific consent form.

Exclusion:

  • History or evidence upon physical examination of CNS disease.
  • Active infection requiring parenteral antibiotics on Day 0. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study.
  • Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agent.
  • Chronic, daily treatment with aspirin or nonsteroidal anti-inflammatory medications.
  • Pregnancy or lactation.
  • Proteinuria at baseline or impairment of renal function.
  • Serious, nonhealing wound, ulcer, or bone fracture.
  • Evidence of bleeding diathesis or coagulopathy
  • Clinically significant cardiovascular disease, congestive heart failure, serous cardiac arrhythmia requiring medication, or significant peripheral vascular disease within 1 year prior to Day 0.
  • History of aneurysms, strokes, transient ischemic attacks, and arteriovenous malformations.
  • Serous concomitant medical or psychiatric disorders.
  • Cohort receiving Capecitabine
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047710

Locations
United States, Texas
University of Texas MDAnderson Cancer Center    
      Houston, Texas, United States, 77030

Sponsors and Collaborators
M.D. Anderson Cancer Center
  More Information

Study ID Numbers:   ID02-146
First Received:   October 14, 2002
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00047710
Health Authority:   United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
pancreatic cancer  
pancreas cancer  
pancreas  

Study placed in the following topic categories:
Capecitabine
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Bevacizumab
Endocrinopathy
Pancrelipase
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on September 05, 2008




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