GON: Efficacy Study of GEMOX Combination and Vinorelbine in NSCL Patients

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00271271

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: oxaliplatine / gemcitabine / Vinorelbine	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2003

Actual Study Completion Date :

Oct 1, 2006

Outcome Measures

Primary Outcome Measures

Objective rate of response (ORR) according to the RECIST criterion, as evaluated by a review panel of outside experts. []

Secondary Outcome Measures

Progression free survival (PFS), Overall survival (OS) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis	Paris		France

Sponsors and Collaborators

Sanofi

Investigators

Study Director: Marie SEBILLE, Dr, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00271271

Other Study ID Numbers:

L_8907

First Posted:

Dec 30, 2005

Last Update Posted:

Dec 7, 2009

Last Verified:

Dec 1, 2009

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Gemcitabine

Vinorelbine

Oxaliplatin

Study Results

No Results Posted as of Dec 7, 2009