Borderline Resectable Pancreatic Cancer: Gemcitabine/Docetaxel And Oxaliplatin Based Chemo/RT

Study Overview

Borderline Resectable Pancreatic Cancer: Gemcitabine/Docetaxel and Oxaliplatin Based Chemo/RT

This study is being conducted to find out what effects (good and bad) that a combination of treatment with chemotherapy, radiation therapy and surgery has on you and your pancreatic cancer. The chemotherapy drugs to be used: Gemcitabine, Docetaxel, Oxaliplatin, 5-FU and alpha-interferon. The goal is to decrease the size of the tumor, so that removal by surgery can be performed. Current treatments for this stage of pancreas cancer offer less than ideal results, with little opportunity for treatment with curative intent.

Subjects must have biopsy proven adenocarcinoma of the pancreas which is bidimensionally measurable on CT. Cancer must be considered locally advanced (not able to be treated surgically). Subjects must not have received prior treatment for pancreatic cancer. Subjects must not have received prior radiation therapy to the abdomen or pelvis (for any reason). Subjects cannot be receiving immunosuppressive therapy (e.g. prednisone, methotrexate). Eligible subjects will receive initial chemotherapy regimen to include eight cycles of Gemcitabine and Docetaxel. All subjects will be re-evaluated for surgery - if tumor has shrunk enough, subject will undergo surgery, followed by additional chemotherapy of Oxaliplatin, 5FU and Alpha-interferon and radiation therapy; once subject has recovered from side effects of the chemo/radiation therapy, they will receive a final chemotherapy regimen of four cycles of Gemcitabine and docetaxel. Subjects who are not surgical candidates after eight cycles of chemotherapy will undergo an additional four cycles of Gemcitabine and docetaxel followed by reassessment for surgery. If they are a surgical candidate, they will undergo surgery followed by chemo/radiation therapy regimen. If they are not a surgical candidate, they will undergo the chemo/radiation therapy regimen. Subjects may be removed from the study treatment for the following reasons: * The investigator feels the subject is not benefitting from treatment * The subject chooses to discontinue for any reason * The subject experiences side effects which are considered to be unacceptable * The subject has an increase in the size of their tumor

Pancreatic Cancer

DRUG: Gemcitabine, Docetaxel, 5FU, Oxaliplatin
BIOLOGICAL: Alpha-interferon
RADIATION: Abdominal/pelvic radiation therapy
PROCEDURE: Pancreaticoduodenectomy

IRB07124
IST14087

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 2008-09-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2010-05-25
First Submitted that Met QC Criteria 2008-09-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2010-05-26
First Posted (ESTIMATED) 2008-09-29	Results First Posted N/A	Last Verified 2010-05

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:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Two year overall survival		two years

Secondary Outcome Measures	Measure Description	Time Frame
median disease free survival initial response rate to gemcitabine/docetaxel (tumor marker and radiographic) toxicity of overall regimen time to disease progression percentage of patients able to complete protocol to entirety		two years

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:

Biopsy proven adenocarcinoma of the pancreas
Tumor must be radiographically bidimensional by abdominal/pelvic CT
Cancer must be locally advanced and not considered immediately treated by standard surgical procedure
No prior therapy for pancreas cancer

Women who are pregnant or lactating
Subjects who have received prior external beam radiation to the abdomen or pelvis
Subjects receiving chronic immunosuppressive therapy (prednisone, methotrexate)

Collaborators and Investigators

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

Sanofi

Investigators

PRINCIPAL_INVESTIGATOR: Vincent Picozzi, MD, Virginia Mason Medical Center

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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Resources

PatientS

Caregivers

Clinical Trial Record