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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Pancreatic Cancer	Drug: Bevacizumab; Drug: Capecitabine; Radiation: Radiotherapy	Phase 1

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	48 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase I Trial of Concurrent RHUMAB VEGF (BEVACIZUMAB) and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer
Study Start Date :	September 2002
Actual Primary Completion Date :	July 2006
Actual Study Completion Date :	July 2006

Arms and Interventions

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Arm

Intervention/treatment

Experimental: Bevacizumab; Radiation, Bevacizumab, and Capecitabine

Drug: 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).; Other Names: Avastin; Anti-VEGF monoclonal antibody; rhuMAb-VEGF Drug: Capecitabine; 650mg/m^2 taken by mouth twice a day 15-52 during the radiotherapy.; Other Name: Xeloda Radiation: Radiotherapy; Radiography given once a day for 5 days at 50.4 Gy in 28 fractions over 5.5 weeks.; Other Name: XRT

Outcome Measures

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Primary Outcome Measures :

1. Safety of combination Radiation, Bevacizumab, and Capecitabine. [ Time Frame: 6 weeks after the completion of therapy ]

Secondary Outcome Measures :

1. 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. ]
2. To evaluate VEGF serum levels before and after anti-VEGF therapy. [ Time Frame: 6 weeks after the completion of therapy. ]
3. 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. ]
4. To evaluate quality of life in patients receiving this therapy. [ Time Frame: 6 weeks after the completion of therapy. ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

M.D. Anderson Cancer Center

Genentech, Inc.

Investigators

Principal Investigator:	Christopher H. Crane, MD	M.D. Anderson Cancer Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

UT MD Anderson Cancer Center website 

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00047710 History of Changes
Other Study ID Numbers:	ID02-146
First Posted:	October 16, 2002
Last Update Posted:	August 1, 2012
Last Verified:	July 2012

Keywords provided by M.D. Anderson Cancer Center:

pancreatic cancer; pancreas cancer; 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; Bevacizumab; Capecitabine	Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action