A Trial Of Chemo & Radiation Therapy For Pancreatic Cancer

Study Overview

A Trial of Chemo & Radiation Therapy for Pancreatic Cancer

This is an open-label, non-randomized, combination study of cetuximab, gemcitabine, 5-FU, and external beam radiotherapy in patients with locally advanced, non-metastatic pancreatic cancer.

During cycle I (chemoradiation), gemcitabine (200 mg/m2) and cetuximab 400mg/m2 initial dose followed by 250mg/m2 IV weekly will be given with continuous infusion 5-FU (200 mg/m2/day) delivered 5 of every 7 days and concurrent external beam radiation therapy. Cetuximab, gemcitabine and 5-FU will begin on the first week of external beam radiotherapy and will continue throughout the course of external beam radiation therapy, and will be discontinued following the conclusion of external beam radiation therapy. All patients will have a central venous access device placed to facilitate chemotherapy administration. During cycles 2 through 5 (chemotherapy), gemcitabine will be administered at a dose of 1000 mg/m2 over 30 minutes followed by cetuximab at a dose of 250mg/m2 over 30 minutes weekly for 3 weeks followed by one-week rest for four cycles.

Pancreatic Cancer

DRUG: Gemcitabine/Fluorouracil with External Beam Radiation

UM200602

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 2007-01-18	Results First Submitted 2016-03-14	Last Update Submitted that met QC Criteria 2017-05-01
First Submitted that Met QC Criteria 2007-01-19	Results First Submitted that Met QC Criteria 2017-05-01	Last Update Posted (ACTUAL) 2017-06-01
First Posted (ACTUAL) 2007-01-22	Results First Posted 2017-06-01	Last Verified 2017-05

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: Gemcitabine/Fluorouracil with External Beam Radiation This protocol will assess the antitumor activity of Gemcitabine/Fluorouracil with External Beam Radiation in patients with non-metastatic, locally advanced pancreatic carcinoma.	DRUG: Gemcitabine/Fluorouracil with External Beam Radiation This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiati

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Gemcitabine/Fluorouracil with External Beam Radiation

This protocol will assess the antitumor activity of Gemcitabine/Fluorouracil with External Beam Radiation in patients with non-metastatic, locally advanced pancreatic carcinoma.

DRUG: Gemcitabine/Fluorouracil with External Beam Radiation

This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiati

Primary Outcome Measures	Measure Description	Time Frame
Progression-free Survival of Patients With Locally Advanced Pancreatic Cancer Treated With Concurrent Gemcitabine, 5-FU, Cetuximab and External Beam Radiation Therapy.	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions	1-year

Secondary Outcome Measures	Measure Description	Time Frame
Biomarker Response to Chemoradiation Therapy	20% decrease in biomarker (CA19-9) from baseline	1-year
Resection Rate		1-Year
Overall Survival		Up to 2 years
Toxicity Associated With 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:

Histological confirmation of pancreatic adenocarcinoma is required.
Only patients with unresectable, non-metastatic tumors are eligible.
Documentation of disease extent by endoscopic ultrasound and either laparotomy or laparoscopy must be performed within 42 days of registration.
All patients will also be assessed by chest x-ray and abdominal-pelvic CT scan.
Confirmation of palliative surgical bypass at the time of laparotomy or whether a biliary stent was placed will be requested.
Disease must be locoregional and not amenable to surgery based on one or more of the following criteria:

size of pancreatic tumor > 5 cm.
lymph nodes (bulky, > 2 cm, but within a radiation port)
vascular involvement or impingement of major vessels (superior mesenteric artery, superior mesenteric vein, portal vein, hepatic artery).
invasion into the adjacent structures.
Patients with either measurable or evaluable disease are eligible.
Patients with evidence of peritoneal seeding by malignancy are not eligible for the study.
Patients with other evidence of metastatic disease are not eligible.
Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, are ineligible.
Patients with any other malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, are ineligible.
Patients may not have had prior therapy for carcinoma of the pancreas, nor prior abdominal radiation therapy.
Age > 18 years.
CTC performance status < 2.
No myocardial infarction in the past six months.
No major surgery in the past two weeks.
No uncontrolled serious medical or psychiatric illness.
Required Initial Laboratory Data:

Total bilirubin < 2.0 mg/dl
AST < 3x upper limits of normal.
Serum creatinine < 2.0 mg/dl
WBC > 3,000/mm3 (ANC>1500/mm3)
Platelets > 100,000 mm3
CA 19-9
Required Diagnostic procedures:

Chest X-ray
Abdominal pelvic CT scan
EUS
Staging laparoscopy or staging laparotomy

Psychiatric illness which would prevent the patient from giving informed consent.
Serious medical illness such as uncontrolled infection, severe cardiovascular disease including recent (< 6 months) myocardial infarction or uncontrolled congestive heart failure, or other serious illness which would limit anticipated survival to < 12 weeks.
Protocol treatment would pose significant risk to an unborn child. Pregnant women should not be enrolled, and women of child-bearing age should be strongly encouraged to practice effective birth control during and for three months after the trial.
Inability to swallow medication. Patients should have adequate, unassisted oral intake.

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Venu Bathini, MD, University of Massachusetts, Worcester

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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