COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Docetaxel in Treating Older Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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: NCT00227708
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : February 13, 2020
Information provided by:

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy drugs may have different effects in older patients.

PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients with locally advanced or metastatic non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: docetaxel Procedure: quality-of-life assessment Phase 2

Detailed Description:



  • Determine the quality of life of older patients with locally advanced or metastatic non-small cell lung cancer treated with docetaxel.


  • Determine the response rate in patients treated with this drug.
  • Determine the overall survival and progression-free survival of patients treated with this drug.
  • Determine the mood status and autonomy of activity of patients treated with this drug.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV twice in week 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed during study therapy in weeks 3-4, 7-8, and 11-12, and then at 6 and 12 months after completion of study treatment.

PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy Regimen With Bi-Weekly Docetaxel in the Treatment of Metastatic or Locally Advanced Non-Small Cell Lung Cancer in Patients Over the Age of 70
Study Start Date : June 2005
Actual Study Completion Date : August 29, 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Primary Outcome Measures :
  1. Quality of life

Secondary Outcome Measures :
  1. Response rate
  2. Overall survival
  3. Progression-free survival
  4. Mood status and autonomy of activity
  5. Toxicity

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   70 Years to 120 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed non-small cell lung cancer, including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or combination of these histologies

    • Stage IIIB (i.e., pleural T4) disease
    • Stage IV disease
    • Recurrent disease after prior surgery or radiotherapy allowed provided disease is in an area that was not previously irradiated
  • Measurable disease by CT scan or MRI
  • No symptomatic brain metastasis
  • Activity of Daily Living Scale score ≥ 4
  • Instrumental Autonomy of Daily Living Scale score ≥ 4



  • 70 and over

Performance status

  • Not specified

Life expectancy

  • More than 3 months


  • Neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin > 10 g/dL


  • Transaminases < 1.5 times normal
  • Bilirubin normal
  • Alkaline phosphatase < 2.5 times normal
  • Pre-albumin > 1.5 mg/dL


  • Creatinine clearance > 30 mL/min


  • No congestive heart failure
  • No unstable angina pectoris
  • No myocardial infarction within the past year
  • No uncontrolled hypertension
  • No uncontrolled high-risk arrhythmias


  • No active peptic ulcer
  • No inflammatory bowel disease


  • No history of dementia or seizures that would preclude giving informed consent
  • No peripheral neuropathy ≥ grade 2
  • No history of significant neurologic disorders


  • No history of hypersensitivity to the study drug or drugs formulated with polysorbate 80
  • No active uncontrolled infection


  • No history of psychotic disorders
  • No uncontrolled diabetes mellitus
  • No absolute contraindication to corticosteroid use
  • No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
  • No geriatric depression scale score ≥ 12/15
  • No familial, social, geographical, or psychological reason that would preclude study follow up


Biologic therapy

  • Not specified


  • No prior chemotherapy for stage IIIB or IV non-small cell lung cancer
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent chronic treatment with corticosteroids except low-dose (i.e., methylprednisolone ≤ 20 mg/day or equivalent) treatment that was initiated > 6 months ago


  • See Disease Characteristics


  • See Disease Characteristics


  • More than 30 days since prior active participation in another therapeutic clinical trial
  • No other concurrent anticancer therapy
  • No other concurrent investigational drugs

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): NCT00227708

Layout table for location information
Centre Medico-Chirurgical de Creil
Creil, France, 60107
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France, 21079
Centre Hospitalier Intercommunal St. Aubin les Elbeuf
Elbeuf, France, 76503
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Institut Curie Hopital
Paris, France, 75248
Clinique De Genolier
Genolier, Switzerland, Ch-1272
United Kingdom
Charing Cross Hospital
London, England, United Kingdom, W6 8RF
Centre for Cancer Research and Cell Biology at Belfast City Hospital
Belfast, Northern Ireland, United Kingdom, BT9 7AB
West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Sponsors and Collaborators
Layout table for investigator information
Study Chair: Pierre Fargeot, MD Centre Georges Francois Leclerc
Layout table for additonal information Identifier: NCT00227708    
Other Study ID Numbers: CDR0000443593
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNICANCER:
adenocarcinoma of the lung
adenosquamous cell lung cancer
large cell lung cancer
squamous cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
Additional relevant MeSH terms:
Layout table for 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