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A Phase I Trial of Concurrent RHUMAB VEGF (BEVACIZUMAB) and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer

Phase 1
Not Enrolling
Pancreatic Cancer

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Trial Information

A Phase I Trial of Concurrent RHUMAB VEGF (BEVACIZUMAB) and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer

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.

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

- Serum bilirubin less than 5mg/dl prior to the start of therapy with adequate biliary

- Adequate bilateral renal function.

- Serum creatinine <1.5 mg/dl.

- Adequate liver function; Alanine aminotransferase (ALT)/aspartate aminotransferase
- 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

- 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

- Serous concomitant medical or psychiatric disorders.

- Cohort receiving Capecitabine

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of combination Radiation, Bevacizumab, and Capecitabine.

Outcome Time Frame:

6 weeks after the completion of therapy

Safety Issue:


Principal Investigator

Christopher H. Crane, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2002

Completion Date:

July 2006

Related Keywords:

  • Pancreatic Cancer
  • pancreatic cancer
  • pancreas cancer
  • pancreas
  • Pancreatic Neoplasms



University of Texas MDAnderson Cancer Center Houston, Texas  77030