Efficacy Study of GEMOX Combination and Vinorelbine in NSCL Patients

Overview

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

Full Title of Study: “Phase II Clinical Trial With the Combination Gemcitabine, Oxaliplatin and Vinorelbine as First Line Treatment in Patients With Non-small Cell Bronchopulmonary Cancer”

Study Type

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

Interventions

  • Drug: oxaliplatine / gemcitabine / Vinorelbine

Clinical Trial Outcome Measures

Primary Measures

  • Objective rate of response (ORR) according to the RECIST criterion, as evaluated by a review panel of outside experts.

Secondary Measures

  • Progression free survival (PFS), Overall survival (OS)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • Medical Affairs Study Director, sanofi-aventis
  • Overall Official(s)
    • Marie SEBILLE, Dr, Study Director, Sanofi

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.