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Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer
This study is currently recruiting participants.
Verified by University of Michigan Cancer Center, July 2008
First Received: April 4, 2007   Last Updated: July 28, 2008   History of Changes
Sponsors and Collaborators: University of Michigan Cancer Center
Sanofi-Aventis
Johns Hopkins University
Princess Margaret Hospital, Canada
Ohio State University
Information provided by: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00456599
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: gemcitabine
Drug: oxaliplatin
Procedure: radiation therapy
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment
Official Title: A Multi-Institutional Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Two-year disease free survival.

Secondary Outcome Measures:
  • Time to Treatment Failure
  • Progression Free Survival
  • Overall Survival

Estimated Enrollment: 68
Study Start Date: April 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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 therapy
    The total dose in a three week treatment block will be 30 Gy in 2.0 Gy fractions.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456599

Contacts
Contact: Mark Zalupski, MD 734-615-3969 zalupski@umich.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21231
Contact: Joseph Herman, MD     410-502-3823     jherma15@jhmi.edu    
Principal Investigator: Joseph Herman, MD            
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Mark Zalupski, MD            
Sub-Investigator: Edgar Ben-Josef, MD            
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Tanios Bekaii-Saab, MD     614-293-9863     Tanios.Bekaii-Saab@osumc.edu    
Principal Investigator: Tanios Bekaii-Saab, MD            
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Laura Dawson, MD     416-946-2125     laura.dawson@rmp.uhn.on.ca    
Principal Investigator: Laura Dawson, MD            
Sponsors and Collaborators
University of Michigan Cancer Center
Sanofi-Aventis
Johns Hopkins University
Princess Margaret Hospital, Canada
Ohio State University
Investigators
Principal Investigator: Mark Zalupski, MD University of Michigan
  More Information

No publications provided

Responsible Party: University of Michigan ( Mark Zalupski, MD )
Study ID Numbers: UMCC 2006.025
Study First Received: April 4, 2007
Last Updated: July 28, 2008
ClinicalTrials.gov Identifier: NCT00456599     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Endocrine System Diseases
Immunosuppressive Agents
Antiviral Agents
Oxaliplatin
Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Oxaliplatin
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 02, 2009