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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00047710

Collaborator

Genentech, Inc. (Industry)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

N/A

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 :

Sep 1, 2002

Actual Primary Completion Date :

Jul 1, 2006

Actual Study Completion Date :

Jul 1, 2006

Arms and Interventions

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 Names: Xeloda Radiation: Radiotherapy Radiography given once a day for 5 days at 50.4 Gy in 28 fractions over 5.5 weeks. Other Names: XRT

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 Names:

Xeloda

Radiation: Radiotherapy

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

Other Names:

XRT

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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