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

Unicancer

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Drug: docetaxel; Procedure: quality-of-life assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT00227708

EU-20521

FRE-FNCLCC-GERICO-05/0501

CDR0000443593

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 70 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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