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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00271271
First received: December 29, 2005
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Non Small Cell Lung Cancer
Drug: oxaliplatine / gemcitabine / Vinorelbine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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)

Estimated Enrollment: 40
Study Start Date: June 2003
Study Completion Date: October 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271271

Locations
France
Sanofi-Aventis
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Marie SEBILLE, Dr Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00271271     History of Changes
Other Study ID Numbers: L_8907
Study First Received: December 29, 2005
Last Updated: December 4, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Gemcitabine
Vinblastine
Vinorelbine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 24, 2014