Efficacy Study of GEMOX Combination and Vinorelbine in NSCL Patients (GON)

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. Identifier: NCT00271271
Recruitment Status : Completed
First Posted : December 30, 2005
Last Update Posted : December 7, 2009
Information provided by:

December 29, 2005
December 30, 2005
December 7, 2009
June 2003
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Objective rate of response (ORR) according to the RECIST criterion, as evaluated by a review panel of outside experts.
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Complete list of historical versions of study NCT00271271 on Archive Site
Progression free survival (PFS), Overall survival (OS)
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Efficacy Study of GEMOX Combination and Vinorelbine in NSCL Patients
Phase II Clinical Trial With the Combination Gemcitabine, Oxaliplatin and Vinorelbine as First Line Treatment in Patients With Non-small Cell Bronchopulmonary Cancer


·To evaluate the activity of the combination of gemcitabine, oxaliplatin and vinorelbine as first line treatment in patients with non-small cell bronchopulmonary cancer


·To evaluate the toxicity of the combination

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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non Small Cell Lung Cancer
Drug: oxaliplatine / gemcitabine / Vinorelbine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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October 2006
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Inclusion Criteria:

  • Non-small cell bronchopulmonary cancer established by histological and/or cytological methods;
  • Advanced or metastatic disease (stage IIIB or IV);
  • At least one measurable lesion with one dimension (>= 20 mm by CT scan or >=10 mm by CT scan) outside of the irradiated area;
  • No prior chemotherapy;
  • Previous radiotherapy permitted as long as there has been a washout period of at least 4 weeks;
  • Age >= 18 years old;
  • ECOG Performance Status (PS): 0-1;
  • Life expectancy >3 months;
  • Hepatic and renal functions and blood count satisfactory:

    • Blood counts: white blood cells >= 3.0 x 10^9/l, neutrophils >= 1.5 x 10^9/l, platelets >= 150 x 10^9/l, haemoglobin >= 9 g/dl,
    • Hepatic function: bilirubin within the limit of the normal upper value, aspartate transaminases (AST) or alanine transaminases (ALT) <= 2.5 times the normal upper value
    • Renal function: creatinine clearance (calculated according to Cockroft and Gault) >= 40 ml/min;
  • Patients of reproductive age must use an effective contraceptive method;
  • Informed consent form signed before any procedure undertaken connected with the study

Exclusion Criteria:

  • Pregnant or breastfeeding patient;
  • Past record of other cancers (excluding basocellular or epidermoid cutaneous carcinoma or cured carcinoma of the cervix);
  • Symptomatic cerebral or leptomeningeal metastases;
  • Symptomatic peripheral neuropathy > 1 (NCI-CTC grade);
  • Presence of a serious disease or medical condition incompatible with the study (at the discretion of the investigator);
  • Treatment with another test product or participation in another therapeutic trial in the 4 weeks preceding inclusion in the study;
  • Concomitant treatment by any other anticancer therapy;
  • Concomitant treatment with phenytoin.

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Medical Affairs Study Director, sanofi-aventis
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Study Director: Marie SEBILLE, Dr Sanofi
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP