Clinical trial NCT00271271: Efficacy Study of GEMOX Combination and Vinorelbine in NSCL Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-12-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 evaluate the toxicity of the combination


Eligibility criteria: 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.

Primary outcomes:
measure: Objective rate of response (ORR) according to the RECIST criterion, as evaluated by a review panel of outside experts.
Secondary outcomes:
measure: Progression free survival (PFS), Overall survival (OS)
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Marie SEBILLE, Dr
role: STUDY_DIRECTOR
References: