NCT00441922

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_3

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

October 29, 2008

Status Verified

October 1, 2008

Enrollment Period

5 years

First QC Date

February 28, 2007

Last Update Submit

October 28, 2008

Conditions

Non Small Cell Lung Cancer

Keywords

CancerElderlyChemotherapyDocetaxelVinorelbine

Outcome Measures

Primary Outcomes (1)

  • Overall survival between the two treatment arms

    1 year

Secondary Outcomes (2)

  • Time to disease progression

    1 year

  • Toxicity profile

    During the time of chemotherapy

Study Arms (2)

1

EXPERIMENTAL

D

Drug: Docetaxel

2

EXPERIMENTAL

V

Drug: Vinorelbine

Interventions

DocetaxelDRUG

Docetaxel at the dose of 38 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles

Also known as: Taxotere
1
VinorelbineDRUG

Vinorelbine at the dose of 25 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles

Also known as: Navelbine
2

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University General Hospital of Alexandroupolis, Department of Medical Oncology

Alexandroupoli, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

IASO General Hospital of Athens, 1st Department of Medical Oncology

Athens, Greece

Location

Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine

Athens, Greece

Location

Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases

Athens, Greece

Location

Sotiria General Hospital, 1st, 3rd, 8th Department of Pulmonary Diseases

Athens, Greece

Location

State General Hospital of Larissa, Department of Medical Oncology

Larissa, Greece

Location

Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology

Piraeus, Greece

Location

Theagenion Anticancer Hospital of Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungNeoplasms

Interventions

DocetaxelVinorelbine

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Lampros Vamvakas, MD

    University Hospital of Crete, Department of Medical Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2007

First Posted

March 1, 2007

Study Start

January 1, 2003

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

October 29, 2008

Record last verified: 2008-10

Locations

GR(10)