This trial is active, not recruiting.

Condition lung cancer
Treatments docetaxel, quality-of-life assessment
Phase phase 2
Start date June 2005
Trial size 58 participants
Trial identifier NCT00227708, CDR0000443593, EU-20521, FRE-FNCLCC-GERICO-05/0501


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Quality of life
time frame:

Secondary Outcomes

Response rate
time frame:
Overall survival
time frame:
Progression-free survival
time frame:
Mood status and autonomy of activity
time frame:
time frame:

Eligibility Criteria

Male or female participants at least 70 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).