Efficacy Study of GEMOX Combination and Vinorelbine in NSCL Patients (GON)

Phase II Clinical Trial With the Combination Gemcitabine, Oxaliplatin and Vinorelbine as First Line Treatment in Patients With Non-small Cell Bronchopulmonary Cancer

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

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: oxaliplatine / gemcitabine / Vinorelbine

• Study Type: Interventional
• Enrollment: 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Progression free survival (PFS), Overall survival (OS)

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Marie SEBILLE, Dr, Sanofi

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Primary Completion: December 6, 2022
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: December 29, 2005
• First Submitted That Met QC Criteria: December 29, 2005
• First Posted (Estimate): December 30, 2005

Study Record Updates

• Last Update Posted (Estimate): December 7, 2009
• Last Update Submitted That Met QC Criteria: December 4, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Gemcitabine; Oxaliplatin; Vinorelbine
• Other Study ID Numbers: L_8907

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No