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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 4, 2007

Last Updated Date

July 28, 2008

Start Date ^†

April 2007

Current Primary Outcome Measures ^†

Two-year disease free survival.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00456599 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Time to Treatment Failure
Progression Free Survival
Overall Survival

Original Secondary Outcome Measures ^†

Time to Treatment Failure
Progression Free Survival
Overall Survival

Descriptive Information

Brief Title ^†

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

Official Title ^†

A Multi-Institutional Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment

Condition ^†

Pancreatic Cancer

Intervention ^†

Drug: gemcitabine
Drug: oxaliplatin
Procedure: radiation therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

December 2013

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Mark Zalupski, MD

734-615-3969

zalupski@umich.edu

Location Countries ^†

United States, Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00456599

Responsible Party

Mark Zalupski, MD, University of Michigan

Secondary IDs ^††

Study Sponsor ^†

University of Michigan Cancer Center

Collaborators ^††

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

Investigators ^†

Principal Investigator:

Mark Zalupski, MD

University of Michigan

Information Provided By

University of Michigan Cancer Center

Verification Date

July 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.