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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00227708
First received: September 26, 2005
Last updated: August 19, 2009
Last verified: December 2006
  Purpose

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 Intervention Phase
Lung Cancer
Drug: docetaxel
Procedure: quality-of-life assessment
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Quality of life [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Mood status and autonomy of activity [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 58
Study Start Date: June 2005
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 70 and over

Performance status

  • Not specified

Life expectancy

  • More than 3 months

Hematopoietic

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

Hepatic

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

Renal

  • Creatinine clearance > 30 mL/min

Cardiovascular

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

Gastrointestinal

  • No active peptic ulcer
  • No inflammatory bowel disease

Neurologic

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

Immunologic

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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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

Radiotherapy

  • See Disease Characteristics

Surgery

  • See Disease Characteristics

Other

  • More than 30 days since prior active participation in another therapeutic clinical trial
  • No other concurrent anticancer therapy
  • No other concurrent investigational drugs
  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: NCT00227708

Locations
France
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
Switzerland
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
UNICANCER
Investigators
Study Chair: Pierre Fargeot, MD Centre de Lutte Contre le Cancer Georges-Francois Leclerc
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00227708     History of Changes
Other Study ID Numbers: CDR0000443593, FRE-FNCLCC-GERICO-05/0501, EU-20521
Study First Received: September 26, 2005
Last Updated: August 19, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014