Efficacy Study of GEMOX Combination and Vinorelbine in NSCL Patients

NCT00271271 | Completed Phase 2

• 1 other identifier: L_8907
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• Progression free survival (PFS), Overall survival (OS)

Interventions

oxaliplatine / gemcitabine / Vinorelbine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Paris, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Oxaliplatin; Gemcitabine; Vinorelbine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Marie SEBILLE, Dr

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 29, 2005
• First Posted: December 30, 2005
• Study Start: June 1, 2003
• Study Completion: October 1, 2006
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

FR (1)