drugset / Trial / NCT00266097
Oxaliplatin, Gemcitabine, Erlotinib, and Radiation Therapy in Treating Patients With Unresectable and/or Metastatic Pancreatic Cancer or Biliary Tract Cancer
Phase 1
Completed
23 enrolled
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI) · collab
Non-randomizedCrossoverOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving oxaliplatin together with gemcitabine, erlotinib, and radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of oxaliplatin, gemcitabine, and erlotinib when given together with radiation therapy in treating patients with unresectable and/or metastatic pancreatic cancer or biliary tract cancer.
Timeline
- Start
- 2004-08
- Primary completion
- 2009-03
- Completion
- 2011-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | 50 mg | Oral |
| Subject | Erlotinib | Small molecule | 75 mg | Oral |
| Subject | Erlotinib | Small molecule | 100 mg | Oral |
| Subject | Erlotinib | Small molecule | 150 mg | Oral |
| Subject | Gemcitabine | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 45 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 60 mg/m2 | Intravenous |