Phase II Trial of Gemcitabine/Paraplatin® (Carboplatin) Followed by Taxol® (Paclitaxel) in Patients With Performance Status = 2,3 or Other Significant Co-Morbidity (HIV Infection or s/p Organ Transplantation) in Advanced Non-Small Cell Lung Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins2 sites in 1 country46 target enrollmentJuly 2005

ConditionsLung Cancer

Drugscarboplatin gemcitabine hydrochloride paclitaxel

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Lung Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Enrollment: 46
Locations: 2
Primary Endpoint: Progression-free survival
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with carboplatin followed by paclitaxel works in treating patients with stage III or stage IV non-small cell lung cancer.

Detailed Description

OBJECTIVES: Primary * Determine the efficacy and tolerability of gemcitabine hydrochloride and carboplatin followed by paclitaxel in patients with stage IIIB-IV non-small cell lung cancer in regard to response rate, median survival, and one year survival. * Determine the toxicity of this regimen in these patients. OUTLINE: This is multicenter study. * Part 1: Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses. In week 7, all patients proceed to part 2 regardless of disease response. * Part 2: Patients receive paclitaxel IV over 1-3 hours once weekly for 6 weeks. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.

Registry

clinicaltrials.gov

Start Date

July 2005

End Date

March 2007

Last Updated

15 years ago

Study Type

Interventional

Sex

All