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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00047710
• Other study ID #: ID02-146
• Status: Completed
• Phase: Phase 1
• First received: October 14, 2002
• Last updated: July 31, 2012
• Start date: September 2002
• Est. completion date: July 2006

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

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

Locations

Country	Name	City	State
United States	University of Texas MDAnderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of combination Radiation, Bevacizumab, and Capecitabine.		6 weeks after the completion of therapy	Yes
Secondary	To evaluate the local tumor response and median survival in patients treated with the above regimen.		6 weeks after the completion of therapy.	No
Secondary	To evaluate VEGF serum levels before and after anti-VEGF therapy.		6 weeks after the completion of therapy.	No
Secondary	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.	No
Secondary	To evaluate quality of life in patients receiving this therapy.		6 weeks after the completion of therapy.	No

External Links

•   UT MD Anderson Cancer Center website