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

NCT00047710 | Completed Phase 1

• 1 other identifier: ID02-146
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; pancreas cancer; pancreas

Outcome Measures

Primary Outcomes (1)

• Safety of combination Radiation, Bevacizumab, and Capecitabine.

  6 weeks after the completion of therapy

Secondary Outcomes (4)

• To evaluate the local tumor response and median survival in patients treated with the above regimen.

  6 weeks after the completion of therapy.

• To evaluate VEGF serum levels before and after anti-VEGF therapy.

  6 weeks after the completion of therapy.

• To evaluate tumor hypoxia via PET scanning (gallium PET with the novel hypoxia tracer Ga-68 ECMN) before, during, and after therapy.

  6 weeks after the completion of therapy.

• To evaluate quality of life in patients receiving this therapy.

  6 weeks after the completion of therapy.

Study Arms (1)

Bevacizumab

EXPERIMENTAL

Radiation, Bevacizumab, and Capecitabine

Drug: Bevacizumab; Drug: Capecitabine; Radiation: Radiotherapy

Interventions

Bevacizumab DRUG

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).

Also known as: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF

Bevacizumab

Capecitabine DRUG

650mg/m\^2 taken by mouth twice a day 15-52 during the radiotherapy.

Also known as: Xeloda

Bevacizumab

Radiotherapy RADIATION

Radiography given once a day for 5 days at 50.4 Gy in 28 fractions over 5.5 weeks.

Also known as: XRT

Bevacizumab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of Texas MDAnderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Bevacizumab; Capecitabine; Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Therapeutics

Study Officials

• Christopher H. Crane, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2002
• First Posted: October 16, 2002
• Study Start: September 1, 2002
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

US (1)