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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00271271
First received: December 29, 2005
Last updated: December 4, 2009
Last verified: December 2009

December 29, 2005
December 4, 2009
June 2003
Not Provided
Objective rate of response (ORR) according to the RECIST criterion, as evaluated by a review panel of outside experts.
Not Provided
Complete list of historical versions of study NCT00271271 on ClinicalTrials.gov Archive Site
Progression free survival (PFS), Overall survival (OS)
Not Provided
Not Provided
Not Provided
 
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

Primary:

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

Secondary:

·To evaluate the toxicity of the combination

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Small Cell Lung Cancer
Drug: oxaliplatine / gemcitabine / Vinorelbine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2006
Not Provided

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00271271
L_8907
No
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Marie SEBILLE, Dr Sanofi
Sanofi
December 2009

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