Randomized Phase II Study of First-Line Treatment With Gemcitabine vs. Erlotinib vs. Gemcitabine and Erlotinib in Elderly Patients With Stage IIIB/IV Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- gemcitabine hydrochloride
- Conditions
- Lung Cancer
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Enrollment
- 147
- Locations
- 11
- Primary Endpoint
- Progression-free Survival
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether gemcitabine and erlotinib are more effective when given alone or together in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying gemcitabine and erlotinib to compare how well they work when given alone or together as first-line therapy in treating older patients with stage IIIB or stage IV non-small cell lung cancer.
Detailed Description
OBJECTIVES: Primary * Compare the progression-free survival rate of older patients with stage IIIB or IV non-small cell lung cancer treated with gemcitabine hydrochloride vs erlotinib hydrochloride vs gemcitabine hydrochloride and erlotinib hydrochloride as first-line therapy. Secondary * Determine the response rate in patients receiving these regimens. * Determine the overall survival rate in patients receiving these regimens. * Determine the toxicity profile of these regimens in these patients. * Determine the quality of life of patients receiving these regimens. OUTLINE: This is a randomized, open-label, controlled, parallel group, multicenter study. Patients are stratified by gender, smoking status (never or light vs current or former), and ECOG performance status (0-1 vs 2). Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive gemcitabine hydrochloride IV on days 1 and 8. Patients with progressive disease may cross over to arm II. * Arm II: Patients receive oral erlotinib hydrochloride daily on days 1-21. * Arm III: Patients receive gemcitabine hydrochloride as in arm I and erlotinib hydrochloride as in arm II. In all arms, treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 2 months for 3 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm A
Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
Intervention: gemcitabine hydrochloride
Arm B
Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
Intervention: erlotinib hydrochloride
Arm C
Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
Intervention: erlotinib hydrochloride
Arm C
Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
Intervention: gemcitabine hydrochloride
Outcomes
Primary Outcomes
Progression-free Survival
Time Frame: Six months
We would consider the combination of gemcitabine plus erlotinib or single agent erlotinib to be worthy of further study if there was an increased progressed-free survival. We would use an increase to 45% progression-free survival at 6 months as significant. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Secondary Outcomes
- Response Rate(Six months)
- Toxicity(After each cycle/3 weeks, up to 3 years)
- Overall Survival(Up to 3 years)
- Quality of Life (QOL)- Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Trial Outcome Index-L (TOI-L)(After each cycle/3 weeks)