GEMOX: Oxaliplatin in Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00261092
First received: December 1, 2005
Last updated: April 14, 2008
Last verified: April 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Multicenter, Open Label Study of Oxaliplatin Combined With Gemcitabine(GEMOX) in Advanced and Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Sanofi:

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
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: NCT00261092

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

No publications provided

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

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014