Vinorelbine and/or Gemcitabine in Treating Older Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Phase 3

• Conditions: Lung Cancer

• Registration Number: NCT00003447
• Lead Sponsor: Istituto Nazionale per lo Studio e la Cura dei Tumori

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of vinorelbine, gemcitabine, or both in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Detailed Description

OBJECTIVES: I. Determine the activity and toxicities of gemcitabine in elderly patients with non-small cell lung cancer. II. Determine the activity and toxicity of the combination of gemcitabine and vinorelbine in these patients. III. Compare the survival rate and quality of life of these patients treated with combination chemotherapy versus single agent chemotherapy. IV. Compare objective response and time to progression of these patients treated with these chemotherapy regimens. V. Compare the toxicities of these three regimens in these patients. VI. Compare the number of hospitalizations, palliative radiation therapies, antibiotic therapies, corticosteroid therapies, analgesic therapies, and hematopoietic growth factor therapies needed for these patients treated with these chemotherapy regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, stage of disease (IIIB vs IV), and performance status (0 vs 1 vs 2). Patients are randomized to one of three treatment arms. Patients receive either vinorelbine IV, gemcitabine IV, or both on days 1 and 8 of each 21 day course. Patients who achieve an objective response or stable disease after 3 courses receive 3 more courses (for a total of 6 courses). Quality of life is assessed before treatment, after course 4 (or 3 weeks after course 3, if therapy is stopped), and at 21 days after course 6 (or 12 weeks after course 3).

PROJECTED ACCRUAL: A total of 630 patients (210 patients per arm) will be accrued for this study.

Study Timeline

• Study Start: 1998-07
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-05-20
• Study First Posted: 2004-05-21
• Status Verified: 2007-09
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Istituto Nazionale per lo Studio e la Cura dei Tumori; 🇮🇹 Naples, Italy