Carboplatin, Paclitaxel, and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
Part of paid clinical trials in Downers Grove, Illinois.
- Sponsor
- Loyola University
- Study ID
- NCT00654836
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- bevacizumab — BIOLOGICALParticipants will receive bevacizumab 15 mg/kg on days 1,22, and 43.
- Carboplatin — DRUGParticipants will receive a standard carboplatin dose according to their area under the plasma drug concentration-time curve (AUC-6) on days 1, 22, and 43.
- ABI-007 — DRUGParticipants will receive ABI-007 (Abraxane) 100mg/m2 on days 1,8, 15, 22, 29, 36,43,and 50.
Study Details
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, 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 bevacizumab, 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 cancer-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving carboplatin and paclitaxel together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel together with bevacizumab works in treating patients with locally recurrent or metastatic breast cancer.
Key Dates
- First listed
- Apr 9, 2008
- Start date
- Oct 31, 2007
- Status verified
- Aug 2017
- Primary completion
- Feb 29, 2012
- Completion
- Sep 30, 2015
Study Design
- Enrollment
- 32 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Carboplatin, ABI-007 and BevacizumabParticipants will receive combination carboplatin, nanoparticle albumin-bound paclitaxel (ABI-007-Abraxane), and bevacizumab (Avastin)
Primary Outcome Measure
Progression-free Survival [ Time Frame: 30 Months ]
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital | Downers Grove | Illinois | 60515-1500 | - |
| Delnor Community Hospital - Geneva | Geneva | Illinois | 60134-4200 | - |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153 | - |
| Edward Hospital Cancer Center | Naperville | Illinois | 60540 | - |
| Swedish-American Regional Cancer Center | Rockford | Illinois | 61104-2315 | - |
| Central Dupage Cancer Center | Winfield | Illinois | 60190-1295 | - |
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