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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: oxaliplatine / gemcitabine / Vinorelbine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00271271

L_8907

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.