NCT00026156

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.)

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	docetaxel
DRUG	vinorelbine tartrate

Timeline

• Start date: 2001-11-01
• Primary completion: 2004-07-01
• Completion: 2008-11-01
• First posted: 2003-01-27
• Last updated: 2013-02-15

Locations

96 sites across 1 country: United States