drugset / Trial / NCT00086957
Gefitinib, Trastuzumab, and Docetaxel in Treating Patients With Metastatic Breast Cancer
Phase 1/2
Completed
31 enrolled
City of Hope Medical Center
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib and trastuzumab with docetaxel may kill more tumor cells. PURPOSE: This phase I/II trial is studying the best dose of docetaxel when given together with gefitinib and trastuzumab in treating patients with metastatic breast cancer.
Timeline
- Start
- 2004-01
- Primary completion
- 2015-08
- Completion
- 2015-08
Publications
- Results Somlo G, Koczywas M, Luu T, et al.: A phase I-II study of trastuzumab, gefitinib, and docetaxel as first line chemotherapy in patients with HER-2 overexpressing stage IV breast carcinoma. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-2035, 2005.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Gefitinib | Small molecule | 250 mg | Oral |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |