Full Text View
Tabular View
No Study Results Posted
Related Studies
Study of Combined RHUMAB VEGF and Capecitabine-Based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer
This study has been completed.
First Received: October 14, 2002   Last Updated: June 19, 2009   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
Genentech
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

Study Type: Interventional
Study Design: Treatment, Open Label, 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

Resource links provided by NLM:


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.

Enrollment: 48
Study Start Date: September 2002
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
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
Genentech
Investigators
Principal Investigator: Christopher H. Crane, MD U.T. M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: U.T. M.D. Anderson Cancer Center ( Christopher H. Crane, MD / Associate Professor )
Study ID Numbers: ID02-146
Study First Received: October 14, 2002
Last Updated: June 19, 2009
ClinicalTrials.gov Identifier: NCT00047710     History of Changes
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:
Antimetabolites
Capecitabine
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Bevacizumab
Pancrelipase
Angiogenesis Inhibitors
Digestive System Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Capecitabine
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Bevacizumab
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Pancreatic Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009