Study Of Gemcitabine And Oxaliplatin With Radiation Therapy In Patients With Pancreatic Cancer

Study Overview

Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer

This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.

This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer. This research treatment will evaluate the combination of two chemotherapy agents, oxaliplatin and gemcitabine with radiation therapy. The researchers have already done studies using oxaliplatin, gemcitabine and radiation therapy together for pancreatic cancer. They want to build on the information they have from this previous research and do the research at multiple sites. They will use this study to determine how well people do who are treated with gemcitabine, oxaliplatin, and radiation therapy prior to having surgery for their pancreatic cancer. The researchers will also gather more information about what type of side effects occur with this treatment.

Pancreatic Cancer

DRUG: gemcitabine
DRUG: oxaliplatin
PROCEDURE: Radiation

UMCC 2006.025
HUM 4531 (OTHER Identifier) (OTHER: University of Michigan IRBMED)

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 2007-04-04	Results First Submitted 2014-03-04	Last Update Submitted that met QC Criteria 2015-11-04
First Submitted that Met QC Criteria 2007-04-04	Results First Submitted that Met QC Criteria 2014-03-04	Last Update Posted (ESTIMATED) 2015-12-03
First Posted (ESTIMATED) 2007-04-05	Results First Posted 2014-04-15	Last Verified 2015-11

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: Oxaliplatin & gemcitabine with radiation This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.	DRUG: gemcitabine Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1, 8, and 15 of a treatment cycle. DRUG: oxaliplatin Oxaliplatin 85mg/m2 will be infused following gemcitabine over approximately 90 minutes on days 1 and 15 of a treatment cycle. PROCEDURE: Radiation The total dose in a three week treatment block will be 30 Gy in 2.0 Gy fractions.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Oxaliplatin & gemcitabine with radiation

This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.

DRUG: gemcitabine

Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1, 8, and 15 of a treatment cycle.

DRUG: oxaliplatin

Oxaliplatin 85mg/m2 will be infused following gemcitabine over approximately 90 minutes on days 1 and 15 of a treatment cycle.

PROCEDURE: Radiation

The total dose in a three week treatment block will be 30 Gy in 2.0 Gy fractions.

Primary Outcome Measures	Measure Description	Time Frame
Two-year Disease Free Survival.	The percent of patients alive and disease-free at two years.	two years

Secondary Outcome Measures	Measure Description	Time Frame
Time to Treatment Failure	Median time for disease recurrence after surgery.	2 years
Overall Survival	Percent overall survival was calculated for all evaluable patients.	5 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:

Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas.
Patients must be deemed resectable or borderline resectable based on criteria in section 4.2 prior to registration.
Patients must have an expected life expectancy of at least 12 weeks and a Zubrod performance status of < 2.
Patients must have adequate organ function defined as follows: absolute neutrophil count of > 1500/mm3, platelets > 100,000/mm3, serum Cr < 1.5 mg/dl, total bilirubin < 3.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary stent).
Patients must be free of other active systemic malignancy, ongoing infection, including HIV infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
Patients must be aware of the investigational nature of the therapy and provide written informed consent.
Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy.
Patients must not have used any investigational agent in the month before enrollment into the study.

Patients with neuroendocrine tumors are excluded.
Patients with preexisting peripheral neuropathy > grade 2 are ineligible.
Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after trial.

Collaborators and Investigators

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

Sanofi
Johns Hopkins University
Princess Margaret Hospital, Canada
Ohio State University

Investigators

PRINCIPAL_INVESTIGATOR: Mark Zalupski, MD, University of Michigan

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

Kim EJ, Ben-Josef E, Herman JM, Bekaii-Saab T, Dawson LA, Griffith KA, Francis IR, Greenson JK, Simeone DM, Lawrence TS, Laheru D, Wolfgang CL, Williams T, Bloomston M, Moore MJ, Wei A, Zalupski MM. A multi-institutional phase 2 study of neoadjuvant gemcitabine and oxaliplatin with radiation therapy in patients with pancreatic cancer. Cancer. 2013 Aug 1;119(15):2692-700. doi: 10.1002/cncr.28117. Epub 2013 May 29.

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Clinical Trial Record