S0027: Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title: Phase II Trial of Sequential Vinorelbine and Docetaxel in Advanced Non-Small Cell Lung Cancer Patients Age Seventy and Older, or With Performance Status 2

Status Completed

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of vinorelbine followed by docetaxel in treating patients who have advanced non-small cell lung cancer.

Clinical Trial Description

OBJECTIVES:

• Determine the survival of patients with advanced non-small cell lung cancer who are either age 70 and over or who have performance status 2, when treated with sequential vinorelbine and docetaxel. (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003.)

• Determine the objective tumor response rates, including confirmed and unconfirmed and complete and partial, in patients treated with this regimen.

• Assess the dose delivered and the reported functional symptom status of patients treated with this regimen.

• Determine the toxic effects of this regimen in these patients.

• Determine the feasibility of performing pharmacokinetic studies and obtaining pharmacokinetic data on these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to age and performance status (age 70 and over with Zubrod 0-1 vs age 18 and over with Zubrod 2). (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003.)

Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Beginning 2 weeks after the last dose of vinorelbine, patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of unacceptable toxicity.

Quality of life is assessed at baseline, at the beginning of courses 2-6, and at week 22.

Patients are followed at week 22, every 3 months for 1 year, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A minimum of 95 patients (55 patients age 70 and over with Zubrod 0-1 and 40 patients age 18 and over with Zubrod 2) will be accrued for this study within 12-18 months. (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003.) ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

• NCT number: NCT00026156
• Study type: Interventional
• Source: Southwest Oncology Group
• Status: Completed
• Phase: Phase 2
• Start date: November 2001
• Completion date: November 2008