Efficacy Study of GEMOX Combination and Vinorelbine in NSCL Patients

Non Small Cell Lung Cancer Clinical Trial

— GON  

Official title:

Phase II Clinical Trial With the Combination Gemcitabine, Oxaliplatin and Vinorelbine as First Line Treatment in Patients With Non-small Cell Bronchopulmonary Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00271271
• Other study ID #: L_8907
• Status: Completed
• Phase: Phase 2
• First received: December 29, 2005
• Last updated: December 4, 2009
• Start date: June 2003
• Est. completion date: October 2006

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• oxaliplatine / gemcitabine / Vinorelbine

Locations

Country	Name	City	State
France	Sanofi-Aventis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective rate of response (ORR) according to the RECIST criterion, as evaluated by a review panel of outside experts.
Secondary	Progression free survival (PFS), Overall survival (OS)