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

February 10, 2020 updated by: UNICANCER

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

58

Phase

  • Phase 2

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

  • France
      • Creil, France, 60107
        • Centre Medico-Chirurgical de Creil
      • Dijon, France, 21079
        • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
      • Elbeuf, France, 76503
        • Centre Hospitalier Intercommunal St. Aubin les Elbeuf
      • Marseille, France, 13273
        • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
      • Paris, France, 75248
        • Institut Curie Hopital
  • Switzerland
      • Genolier, Switzerland, Ch-1272
        • Clinique de Genolier
  • United Kingdom
    • England
      • London, England, United Kingdom, W6 8RF
        • Charing Cross Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT9 7AB
        • Centre for Cancer Research and Cell Biology at Belfast City Hospital
    • Scotland
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • West of Scotland Cancer Centre

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

70 years to 120 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Quality of life

Secondary Outcome Measures

Outcome Measure
Toxicity
Response rate
Progression-free survival
Overall survival
Mood status and autonomy of activity

Collaborators and Investigators

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

Sponsor

UNICANCER

Investigators

  • Study Chair: Pierre Fargeot, MD, Centre Georges Francois Leclerc

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

June 1, 2005

Study Completion (Actual)

August 29, 2006

Study Registration Dates

First Submitted

September 26, 2005

First Submitted That Met QC Criteria

September 26, 2005

First Posted (Estimate)

September 28, 2005

Study Record Updates

Last Update Posted (Actual)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000443593
  • FRE-FNCLCC-GERICO-05/0501
  • EU-20521

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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