Efficacy Study of GEMOX Combination and Vinorelbine in NSCL Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2006-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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oxaliplatine / gemcitabine / Vinorelbine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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sanofi-aventis

Principal Investigators

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Marie SEBILLE, Dr

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Paris, , France

Site Status

Countries

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France

Other Identifiers

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L_8907

Identifier Type: -

Identifier Source: org_study_id