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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Capecitabine
Radiotherapy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer, pancreas cancer, pancreas

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Criteria: 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

Sites / Locations

  • University of Texas MDAnderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bevacizumab

Arm Description

Radiation, Bevacizumab, and Capecitabine

Outcomes

Primary Outcome Measures

Safety of combination Radiation, Bevacizumab, and Capecitabine.

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.

Full Information

First Posted
October 14, 2002
Last Updated
July 31, 2012
Sponsor
M.D. Anderson Cancer Center
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00047710
Brief Title
Study of Combined RHUMAB VEGF and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer
Official Title
A Phase I Trial of Concurrent RHUMAB VEGF (BEVACIZUMAB) and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
pancreatic cancer, pancreas cancer, pancreas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab
Arm Type
Experimental
Arm Description
Radiation, Bevacizumab, and Capecitabine
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
Intervention Description
Beginning 2 weeks prior to radiotherapy, dose of 5 mg/kg by vein then of 2.5 mg/kg during radiotherapy for four weeks every 2 weeks (three doses).
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
650mg/m^2 taken by mouth twice a day 15-52 during the radiotherapy.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
XRT
Intervention Description
Radiography given once a day for 5 days at 50.4 Gy in 28 fractions over 5.5 weeks.
Primary Outcome Measure Information:
Title
Safety of combination Radiation, Bevacizumab, and Capecitabine.
Time Frame
6 weeks after the completion of therapy
Secondary Outcome Measure Information:
Title
To evaluate the local tumor response and median survival in patients treated with the above regimen.
Time Frame
6 weeks after the completion of therapy.
Title
To evaluate VEGF serum levels before and after anti-VEGF therapy.
Time Frame
6 weeks after the completion of therapy.
Title
To evaluate tumor hypoxia via PET scanning (gallium PET with the novel hypoxia tracer Ga-68 ECMN) before, during, and after therapy.
Time Frame
6 weeks after the completion of therapy.
Title
To evaluate quality of life in patients receiving this therapy.
Time Frame
6 weeks after the completion of therapy.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher H. Crane, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MDAnderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center website

Learn more about this trial

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

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