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Phase I/II Trial of Radiation, Avastin and Tarceva for Pancreatic Adenocarcinoma

NCT00735306 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-06-18

Study results available
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Summary

The primary purpose of this trial is to define the maximum tolerated and/or recommended phase II dose of the combination of Avastin and Tarceva in patients undergoing radiation therapy for carcinoma of the pancreas. An additional primary objective is to describe the frequency and nature of grade III/IV and grade I/II toxicities associated with this regimen. Secondary objectives include describing 1-year disease-free survival and overall survival rates as well as to estimate clinical and pathologic complete response rates associated with this regimen.

Conditions

Interventions

DRUG

Avastin

Avastin 10 mg/kg IV on days 1, 15 and 29 Begins the first day of radiation therapy

DRUG

Tarceva

Daily by mouth per assigned dose, for 5.5 weeks Begins the first day of radiation therapy

RADIATION

Radiation Therapy

Radiation to the pancreas Monday through Friday for 28 treatments

Sponsors & Collaborators

Principal Investigators

  • Brian Czito, MD · Duke University Medical Center, Dept Radiation Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-08-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00735306 on ClinicalTrials.gov