Phase I/II Trial Of Radiation, Avastin And Tarceva For Pancreatic Adenocarcinoma

Study Overview

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

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.

This is a phase I/II study in which up to 18 patients will be enrolled in the phase I portion and up to an additional 26 patients in the phase II portion. Patients will be treated with Tarceva (cohort specified dose), along with fixed doses of Avastin and radiation therapy. Avastin will be given as an IV dose on days 1, 15, and 29. Tarceva will be given as a once daily by mouth. On radiation days Tarceva will be taken immediately before or after XRT. XRT will be given to a total dose of 50.4 Gy in 28 fractions, each fraction given once daily on Monday through Friday for 5.5 weeks

Pancreatic Cancer

DRUG: Avastin
DRUG: Tarceva
RADIATION: Radiation Therapy

Pro00001597

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2008-08-13	Results First Submitted 2011-10-14	Last Update Submitted that met QC Criteria 2015-05-22
First Submitted that Met QC Criteria 2008-08-13	Results First Submitted that Met QC Criteria 2011-10-14	Last Update Posted (ESTIMATED) 2015-06-18
First Posted (ESTIMATED) 2008-08-14	Results First Posted 2011-11-24	Last Verified 2015-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 1 Avastin, Tarceva and Radiation Therapy	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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 1

Avastin, Tarceva and Radiation Therapy

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

Primary Outcome Measures	Measure Description	Time Frame
Tarceva Maximum Tolerated Dose in mg	Tarceva maximum tolerated dose in mg	1 yr

Secondary Outcome Measures	Measure Description	Time Frame
Number of Dose Limiting Toxicities		Within 30 days of completing radiation
One Year Overall Survival From Time of Diagnosis	One year survival from time of diagnosis for patients who completed this regimen	1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Age > 18 years
Histologically and/or cytologically confirmed adenocarcinoma of the pancreas, T1-4, N0-1, M0. Patients should have disease for which combined modality therapy is indicated.
Performance status 0-2
Life expectancy > 3 months
Adequate hematologic, renal, hepatic function
Calculated creatinine Cl > 50 mL/min
Use of effective means of contraception in patients of child-bearing potential.

No prior therapy for pancreatic cancer
Previous treatment with bevacizumab or erlotinib
Evidence of duodenal invasion or gastric outlet obstruction
Presence of bleeding diathesis or coagulopathy
History or prior arterial thrombotic event
Conditions leading to inadequate gastrointestinal tract absorption
Poorly controlled diarrhea .
Presence of baseline proteinuria or renal dysfunction (CrCl < 50 (Cockcroft-Gault equation)
Inadequately controlled hypertension
New York Heart Association (NYHA) Grade II or greater congestive heart failure
Clinically significant peripheral vascular disease
Presence of central nervous system or brain metastases
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
Pregnant or lactating females
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
Serious, non-healing wound, ulcer, or bone fracture
Inability to comply with study and/or follow-up procedures
Treatment for other carcinomas within the last five years, except cured non-melanoma skin cancer, curatively treated in-situ cervical cancer, or localized prostate cancer with a current PSA of <1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry.
Comorbid conditions that would complicate safety or compliance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Genentech, Inc.

Investigators

PRINCIPAL_INVESTIGATOR: Brian Czito, MD, Duke University Medical Center, Dept Radiation Oncology

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record