drugset / Trial / NCT00680758
Cisplatin, Paclitaxel, and Everolimus in Treating Patients With Metastatic Breast Cancer
Phase 1
Completed
18 enrolled
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) together with everolimus may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of cisplatin, paclitaxel, and everolimus when given together for the treatment of patients with metastatic breast cancer.
Timeline
- Start
- 2008-05
- Primary completion
- 2009-08
- Completion
- 2010-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Everolimus | Small molecule | 20 mg/m2 | Oral |
| Subject | Everolimus | Small molecule | 25 mg/m2 | Oral |
| Subject | Everolimus | Small molecule | 30 mg/m2 | Oral |
| Subject | Paclitaxel | Small molecule | 65 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 70 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |