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Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00242190
First Posted: October 19, 2005
Last Update Posted: November 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi-Synthelabo
Information provided by:
University of Michigan Cancer Center
  Purpose
This study will examine a proposed research treatment which evaluates the addition of oxaliplatin, a chemotherapy agent, to gemcitabine, another chemotherapy agent, and radiation therapy for the treatment of patients with pancreatic cancer. The researchers have already done studies using gemcitabine and radiation therapy together. They want to build on the information they have from this previous research. The researchers believe that the combination chemotherapy with radiation is worth investigating to treat pancreatic cancer. They will use this study to determine what type of side effects occur with this treatment and to assess how effective the treatment is at controlling the cancer.

Condition Intervention Phase
Pancreatic Neoplasms Drug: oxaliplatin Drug: gemcitabine Procedure: radiation therapy Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Occurrence of dose limiting toxicity up to three weeks following the second cycle of chemotherapy.

Secondary Outcome Measures:
  • Characterize pattern of responses, progression free survival, and survival after treatment

Estimated Enrollment: 40
Study Start Date: June 2004
Study Completion Date: February 2010
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas.
  • Patients may have any stage of pancreatic cancer but if metastatic, systemic disease burden should be asymptomatic and small in volume.
  • Determination of resectability must be made prior to registration.
  • Patients must have an estimated 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, 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 of reproductive potential must have agreed to use an effective contraceptive method during participation in this trial and for 6 months after trial.
  • Patient must be aware of the investigational nature of the therapy and provide written informed consent.

Exclusion Criteria:

  • Patients with neuroendocrine tumors are excluded.
  • Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy.
  • Patient must not have used any investigational agent in the month before enrollment into the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00242190


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Sanofi-Synthelabo
Investigators
Principal Investigator: Mark Zalupski, MD University of Michigan
  More Information

ClinicalTrials.gov Identifier: NCT00242190     History of Changes
Other Study ID Numbers: UMCC 2003-082
First Submitted: October 18, 2005
First Posted: October 19, 2005
Last Update Posted: November 15, 2010
Last Verified: November 2010

Keywords provided by University of Michigan Cancer Center:
drug therapy
radiotherapy
clinical trial

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
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs