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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00227708
• Other study ID #: CDR0000443593
• Secondary ID: FRE-FNCLCC-GERIC
• Status: Completed
• Phase: Phase 2
• Start date: June 2005
• Est. completion date: August 29, 2006

Study information

• Verified date: February 2020
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 29, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• docetaxel

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
France	Centre Medico-Chirurgical de Creil	Creil
France	Centre de Lutte Contre le Cancer Georges-Francois Leclerc	Dijon
France	Centre Hospitalier Intercommunal St. Aubin les Elbeuf	Elbeuf
France	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	Marseille
France	Institut Curie Hopital	Paris
Switzerland	Clinique De Genolier	Genolier
United Kingdom	Centre for Cancer Research and Cell Biology at Belfast City Hospital	Belfast	Northern Ireland
United Kingdom	West of Scotland Cancer Centre	Glasgow	Scotland
United Kingdom	Charing Cross Hospital	London	England

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Countries where clinical trial is conducted

France,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life
Secondary	Response rate
Secondary	Overall survival
Secondary	Progression-free survival
Secondary	Mood status and autonomy of activity
Secondary	Toxicity