Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
GEMOX: Oxaliplatin in Pancreatic Cancer
This study has been completed.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00261092
  Purpose

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

Condition Intervention Phase
Pancreatic Neoplasms
Drug: Oxaliplatin
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Oxaliplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Multicenter, Open Label Study of Oxaliplatin Combined With Gemcitabine(GEMOX) in Advanced and Metastatic Pancreatic Cancer

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Overall response rate based on RECIST criteria

Secondary Outcome Measures:
  • Time to progression
  • Overall survival
  • Clinical benefit
  • Quality of life

Estimated Enrollment: 48
Study Start Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261092

Locations
Korea, Republic of
Sanofi-Aventis
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Won-Sik Lee, MD sanofi-avents
  More Information

CSR Synopsis  This link exits the ClinicalTrials.gov site

Study ID Numbers: PM_L_0126
Study First Received: December 1, 2005
Last Updated: April 14, 2008
ClinicalTrials.gov Identifier: NCT00261092  
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:
Oxaliplatin
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009