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

M.D. Anderson Cancer Center1 site in 1 country48 target enrollmentSeptember 2002

ConditionsPancreatic Cancer

InterventionsBevacizumab Capecitabine Radiotherapy

DrugsBevacizumab Capecitabine

Overview

Phase: Phase 1
Intervention: Bevacizumab
Conditions: Pancreatic Cancer
Sponsor: M.D. Anderson Cancer Center
Enrollment: 48
Locations: 1
Primary Endpoint: Safety of combination Radiation, Bevacizumab, and Capecitabine.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2002

End Date

July 2006

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

M.D. Anderson Cancer Center

Responsible Party

Sponsor

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 \>/=
•No upper age restriction.
•Absolute granulocyte count \>1,500 cells/mm3 and platelet count at least 100,000 cells/mm
•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.

Exclusion Criteria

•History or evidence upon physical examination of CNS disease.
•Active infection requiring parenteral antibiotics on Day
•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

Arms & Interventions

Bevacizumab

Radiation, Bevacizumab, and Capecitabine

Intervention: Bevacizumab

Bevacizumab

Radiation, Bevacizumab, and Capecitabine

Intervention: Capecitabine

Bevacizumab

Radiation, Bevacizumab, and Capecitabine

Intervention: Radiotherapy

Outcomes

Primary Outcomes

Safety of combination Radiation, Bevacizumab, and Capecitabine.

Time Frame: 6 weeks after the completion of therapy

Secondary Outcomes

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 VEGF serum levels before and after anti-VEGF 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.)
To evaluate the local tumor response and median survival in patients treated with the above regimen.(6 weeks after the completion of therapy.)