NCT00227708

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 70 Years – 120 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	docetaxel
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2005-06-01
• Completion: 2006-08-29
• First posted: 2005-09-28
• Last updated: 2020-02-13

Locations

9 sites across 3 countries: France, Switzerland, United Kingdom