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

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Johns Hopkins University
Princess Margaret Hospital, Canada
Ohio State University
Information provided by (Responsible Party):
Mark Zalupski, M.D., University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00456599
First received: April 4, 2007
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Pancreatic Cancer
Drug: gemcitabine
Drug: oxaliplatin
Procedure: Radiation
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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. [ Time Frame: two years ] [ Designated as safety issue: No ]
    The percent of patients alive and disease-free at two years.


Secondary Outcome Measures:
  • Time to Treatment Failure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Median time for disease recurrence after surgery.

  • Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Percent overall survival was calculated for all evaluable patients.


Enrollment: 71
Study Start Date: April 2007
Study Completion Date: January 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Gemzar
Drug: oxaliplatin
Oxaliplatin 85mg/m2 will be infused following gemcitabine over approximately 90 minutes on days 1 and 15 of a treatment cycle.
Other Name: Eloxatin
Procedure: Radiation
The total dose in a three week treatment block will be 30 Gy in 2.0 Gy fractions.
Other Name: RT

Detailed Description:

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456599

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University of Michigan Cancer Center
Sanofi
Johns Hopkins University
Princess Margaret Hospital, Canada
Ohio State University
Investigators
Principal Investigator: Mark Zalupski, MD University of Michigan
  More Information

Publications:
Responsible Party: Mark Zalupski, M.D., Principal Investigator, University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00456599     History of Changes
Other Study ID Numbers: UMCC 2006.025, HUM 4531
Study First Received: April 4, 2007
Results First Received: March 4, 2014
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 01, 2014