Trial of Docetaxel Versus Vinorelbine as 1st Line Treatment in Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00441922
Recruitment Status : Completed
First Posted : March 1, 2007
Last Update Posted : October 29, 2008
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group

Brief Summary:
This trial will compare the efficacy of docetaxel versus vinorelbine as first-line treatment in elderly patients with advanced NSCLC.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Docetaxel Drug: Vinorelbine Phase 3

Detailed Description:
Docetaxel and vinorelbine are well known active agents in the treatment of NSCLC. The standard treatment of elderly patients with advanced NSCLC is monotherapy with a third generation agent. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Phase II Study of Docetaxel Versus Vinorelbine as First-Line Treatment in Elderly Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)
Study Start Date : January 2003
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: Docetaxel
Docetaxel at the dose of 38 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
Other Name: Taxotere
Experimental: 2
Drug: Vinorelbine
Vinorelbine at the dose of 25 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
Other Name: Navelbine

Primary Outcome Measures :
  1. Overall survival between the two treatment arms [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Time to disease progression [ Time Frame: 1 year ]
  2. Toxicity profile [ Time Frame: During the time of chemotherapy ]

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Ages Eligible for Study:   65 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer
  • Stage IIIB/IV
  • No prior chemotherapy
  • Existence of two-dimensional measurable disease. The measurable disease should not have been irradiated
  • Life expectancy of more than 3 months
  • Age ≥ 65 years
  • Performance status (WHO) ≤ 3
  • Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, Hemoglobin > 9 gr/mm^3)
  • Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal), and renal function (creatinine < 2 mg/dl)
  • Informed consent

Exclusion Criteria:

  • Psychiatric illness or social situation that would preclude study compliance.
  • Other concurrent uncontrolled illness
  • Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No absence or irradiated and stable central nervous system metastatic disease.
  • No presence of a reliable care giver
  • Other concurrent investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00441922

University General Hospital of Alexandroupolis, Department of Medical Oncology
Alexandroupolis, Greece
401 Military Hospital of Athens
Athens, Greece
Air Forces Military Hospital of Athens
Athens, Greece
IASO General Hospital of Athens, 1st Department of Medical Oncology
Athens, Greece
Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine
Athens, Greece
Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases
Athens, Greece
Sotiria General Hospital, 1st, 3rd, 8th Department of Pulmonary Diseases
Athens, Greece
State General Hospital of Larissa, Department of Medical Oncology
Larissa, Greece
Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology
Piraeus, Greece
Theagenion Anticancer Hospital of Thessaloniki
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Principal Investigator: Lampros Vamvakas, MD University Hospital of Crete, Department of Medical Oncology

Responsible Party: L.Vamvakas, Hellenic Oncology Research Group Identifier: NCT00441922     History of Changes
Other Study ID Numbers: CT/03.07
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: October 29, 2008
Last Verified: October 2008

Keywords provided by Hellenic Oncology Research Group:

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic