GEMOX: Oxaliplatin in Pancreatic Cancer

April 14, 2008 updated by: Sanofi

Phase II Multicenter, Open Label Study of Oxaliplatin Combined With Gemcitabine(GEMOX) in Advanced and Metastatic 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall response rate based on RECIST criteria

Secondary Outcome Measures

Outcome Measure
Time to progression
Overall survival
Quality of life
Clinical benefit

Collaborators and Investigators

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

Sponsor

Sanofi

Investigators

  • Study Director: Won-Sik Lee, MD, sanofi-avents

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 Major Dates

Study Start

October 1, 2005

Study Registration Dates

First Submitted

December 1, 2005

First Submitted That Met QC Criteria

December 1, 2005

First Posted (Estimate)

December 2, 2005

Study Record Updates

Last Update Posted (Estimate)

April 15, 2008

Last Update Submitted That Met QC Criteria

April 14, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM_L_0126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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