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GEMOX: Oxaliplatin in Pancreatic Cancer


2005-10


N/A


N/A


48

Study Overview

GEMOX: Oxaliplatin in Pancreatic Cancer

Primary objective: * To evaluate overall response rate (based on RECIST criterion) Secondary objective: * To evaluate time to progression, clinical benefit, quality of life and safety

N/A

  • Pancreatic Neoplasms
  • DRUG: Oxaliplatin
  • PM_L_0126

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

2005-12-01  

N/A  

2008-04-14  

2005-12-01  

N/A  

2008-04-15  

2005-12-02  

N/A  

2008-04  

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:
Non Randomized


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
Primary Outcome MeasuresMeasure DescriptionTime Frame
Overall response rate based on RECIST criteria
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Time to progression
Overall survival
Clinical benefit
Quality of life

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:

    Inclusion Criteria:

  • Histologically proven adenocarcinoma of the pancreas
  • Metastatic or locally advanced, non resectable disease(Non resectable disease will be determined by the investigators with clinical data)
  • Uni-dimensionally measurable disease as defined by RECIST (primary or secondary tumors>2cm using conventional CT scan or ≥1cm with spiral CT scan)
  • No previous chemo or radiotherapy, but postoperative radiotherapy as a adjuvant therapy for non-target lesion is permitted
  • Karnofsky Performance Status (KPS) ≥60
  • No known Central Nervous System metastases
  • No sensory neuropathy at inclusion
  • Biological and hematological evaluation < 2 weeks prior to treatment administration:


  • Neutrophils ≥ 1500/ mm3
  • Platelets ≥ 100,000/mm3
  • Alkaline phosphatases< 5X ULN(upper Limits of Normal) and Bilirubin < 1.5X ULN
  • SGOT,SGPT <2.5 X ULN if no liver metastasis
  • SGOT,SGPT <5 X ULN if liver metastasis
  • Creatinine < 1.5 X ULN
  • Baseline imaging (CT scan or Magnetic Resonance Imaging) <3 weeks before treatment administration
  • Men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. Subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children

  • Exclusion Criteria:

  • Corticotherapy except for anti-emetic purpose
  • Pregnant or breast feeding women (Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs)
  • Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia
  • Uncontrolled or persistent hypercalcemia
  • History of significant neurologic or psychiatric disorders
  • Vater ampulomas and biliary tract adenocarcinomas
  • Other -non cured- malignancies

  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Collaborators and Investigators

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


    • STUDY_DIRECTOR: Won-Sik Lee, MD, sanofi-avents

    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

    No publications available