drugset / Trial / NCT00283244
Ph II Gemcitabine, Erlotinib, and Gemcitabine With Erlotinib/Elderly Patients W/ IIIB/IV NSCLC
Phase 2
Completed
147 enrolled
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI) · collab
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2006-03
- Primary completion
- 2014-09
- Completion
- 2014-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | 100 mg | Oral |
| Subject | Erlotinib | Small molecule | 150 mg | Oral |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1200 mg/m2 | Intravenous |