Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/Neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer
NCT00068757 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2012-09-12
Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Lonafarnib 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. Combining lonafarnib and trastuzumab with paclitaxel may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lonafarnib when given together with trastuzumab and paclitaxel in treating patients with HER2/neu-overexpressing stage IIIB, stage IIIC, or stage IV breast cancer.
Conditions
Interventions
- BIOLOGICAL
- DRUG
-
lonafarnib
- DRUG
- OTHER
-
pharmacological study
Sponsors & Collaborators
-
European Organisation for Research and Treatment of Cancer - EORTC
lead NETWORK
Principal Investigators
-
Jan H. M. Schellens, MD, PhD · The Netherlands Cancer Institute
Study Design
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-08-31
- Primary Completion
- 2007-11-30
Countries
- Belgium
- France
- Netherlands
Study Locations
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