Study of Combined RHUMAB VEGF and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer
NCT ID: NCT00047710
Last Updated: 2012-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2002-09-30
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bevacizumab
Radiation, Bevacizumab, and Capecitabine
Bevacizumab
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).
Capecitabine
650mg/m\^2 taken by mouth twice a day 15-52 during the radiotherapy.
Radiotherapy
Radiography given once a day for 5 days at 50.4 Gy in 28 fractions over 5.5 weeks.
Interventions
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Bevacizumab
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).
Capecitabine
650mg/m\^2 taken by mouth twice a day 15-52 during the radiotherapy.
Radiotherapy
Radiography given once a day for 5 days at 50.4 Gy in 28 fractions over 5.5 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
Yes
Sponsors
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Genentech, Inc.
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Christopher H. Crane, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MDAnderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center website
Other Identifiers
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ID02-146
Identifier Type: -
Identifier Source: org_study_id