Clinical trial NCT00227708: Docetaxel in Treating Older Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: 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
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2005-09-28
Enrollment: 58
Sex: ALL
Minimum age (years): 70
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Quality of life
Secondary outcomes:
measure: Response rate
measure: Overall survival
measure: Progression-free survival
measure: Mood status and autonomy of activity
measure: Toxicity
Other outcomes:
Locations:
city: Creil
country: France
facility: Centre Medico-Chirurgical de Creil
city: Dijon
country: France
facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc
city: Elbeuf
country: France
facility: Centre Hospitalier Intercommunal St. Aubin les Elbeuf
city: Marseille
country: France
facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
city: Paris
country: France
facility: Institut Curie Hopital
city: Genolier
country: Switzerland
facility: Clinique De Genolier
city: London
country: United Kingdom
facility: Charing Cross Hospital
state: England
city: Belfast
country: United Kingdom
facility: Centre for Cancer Research and Cell Biology at Belfast City Hospital
state: Northern Ireland
city: Glasgow
country: United Kingdom
facility: West of Scotland Cancer Centre
state: Scotland
Study officials:
affiliation: Centre Georges Francois Leclerc
name: Pierre Fargeot, MD
role: STUDY_CHAIR
References: