Status:
COMPLETED
Efficacy Study of GEMOX Combination and Vinorelbine in NSCL Patients
Lead Sponsor:
Sanofi
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 eval...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00271271
Start Date
June 1 2003
End Date
October 1 2006
Last Update
December 7 2009
Active Locations (1)
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1
Sanofi-Aventis
Paris, France