NCT00041314

Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer

A Phase II Trial Of Carboplatin And Gemcitabine With Exisulind In Patients With Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 Years – 120 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of carboplatin, gemcitabine, and exisulind in treating patients who have advanced non-small cell lung cancer.

Detailed description

OBJECTIVES: * Determine the 18-month survival rate in patients with advanced non-small cell lung cancer treated with carboplatin, gemcitabine, and exisulind. * Determine the feasibility and toxicity of this regimen in these patients. * Determine the response rate, progression-free survival, and overall median survival of patients treated with this regimen. OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Chemotherapy repeats every 21 days for up to 6 courses. Patients also receive oral exisulind twice daily beginning on day 1 of course 1 and continuing until disease progression or unacceptable toxicity occurs. Patients are followed every 3 months for 2 years and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 6 months.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	exisulind
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 2002-10-04
• Primary completion: 2005-07-01
• Completion: 2007-06-15
• First posted: 2003-01-27
• Last updated: 2023-06-15

Locations

79 sites across 4 countries: United States, Australia, Puerto Rico, South Africa