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

NCT ID: NCT00227708

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2006-08-29

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.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

docetaxel

Intervention Type: DRUG

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Principal Investigators

Pierre Fargeot, MD

Role: STUDY_CHAIR

Centre Georges Francois Leclerc

Locations

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, , France

Clinique De Genolier

Genolier, , Switzerland

Charing Cross Hospital

London, England, 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

Countries

France; Switzerland; United Kingdom

Other Identifiers

FRE-FNCLCC-GERICO-05/0501

Identifier Type: -

Identifier Source: secondary_id

EU-20521

Identifier Type: -

Identifier Source: secondary_id

CDR0000443593

Identifier Type: -

Identifier Source: org_study_id