Trials / Completed
CompletedNCT01288261
Paclitaxel and Bavituximab in Treating Patients With HER2-Negative Metastatic Breast Cancer
A Phase I Trial of Weekly Paclitaxel in Combination With Bavituximab in Patients With Her-2 Negative Metastatic Breast Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- University of Arizona · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bavituximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel together with bavituximab may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects of giving paclitaxel and bavituximab together in treating patients with Human Epidermal growth factor Receptor 2 (HER2 )-negative metastatic breast cancer
Detailed description
PRIMARY OBJECTIVES: I. To determine the safety, feasibility, and tolerability of combining paclitaxel with weekly bavituximab therapy. SECONDARY OBJECTIVES: I. To describe changes in pharmacodynamic markers and coagulation markers in response to single agent and combined therapy. OUTLINE: Patients receive paclitaxel intravenously (IV) on days 1, 8, and 15 and bavituximab IV on days 1, 8, 15, and 22 (days 15 and 22 only of course 1). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.
Conditions
- Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Male Breast Cancer
- Recurrent Breast Cancer
- Stage IIIC Breast Cancer
- Stage IV Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | paclitaxel | Given IV |
| BIOLOGICAL | bavituximab | Given IV |
| OTHER | laboratory biomarker analysis | Correlative studies |
| OTHER | pharmacological study | Correlative study |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2013-05-01
- Completion
- 2015-07-01
- First posted
- 2011-02-02
- Last updated
- 2016-04-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01288261. Inclusion in this directory is not an endorsement.