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

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ClinicalTrials.gov Identifier: NCT00227708
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : September 28, 2005
Last Update Posted : August 20, 2009
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE September 26, 2005
First Posted Date  ICMJE September 28, 2005
Last Update Posted Date August 20, 2009
Study Start Date  ICMJE June 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2007)
Quality of life
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00227708 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2007)
  • Response rate
  • Overall survival
  • Progression-free survival
  • Mood status and autonomy of activity
  • Toxicity
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Docetaxel in Treating Older Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Official Title  ICMJE 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
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: docetaxel
  • Procedure: quality-of-life assessment
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
58
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00227708
Other Study ID Numbers  ICMJE CDR0000443593
FRE-FNCLCC-GERICO-05/0501
EU-20521
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE UNICANCER
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Pierre Fargeot, MD Centre Georges Francois Leclerc
PRS Account National Cancer Institute (NCI)
Verification Date December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP