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

October 28, 2008 updated by: Hellenic Oncology Research Group

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

166

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Alexandroupolis, Greece
        • University General Hospital of Alexandroupolis, Department of Medical Oncology
      • Athens, 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
      • Larissa, Greece
        • State General Hospital of Larissa, Department of Medical Oncology
      • Piraeus, Greece
        • Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology
      • Thessaloniki, Greece
        • Theagenion Anticancer Hospital of Thessaloniki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
D
Drug: Docetaxel
Docetaxel at the dose of 38 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
Other Names:
  • Taxotere
Experimental: 2
V
Drug: Vinorelbine
Vinorelbine at the dose of 25 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
Other Names:
  • Navelbine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival between the two treatment arms
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to disease progression
Time Frame: 1 year
1 year
Toxicity profile
Time Frame: During the time of chemotherapy
During the time of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

Investigators

  • Principal Investigator: Lampros Vamvakas, MD, University Hospital of Crete, Department of Medical Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

February 28, 2007

First Submitted That Met QC Criteria

February 28, 2007

First Posted (Estimate)

March 1, 2007

Study Record Updates

Last Update Posted (Estimate)

October 29, 2008

Last Update Submitted That Met QC Criteria

October 28, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/03.07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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