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 — BIOLOGICAL
    Participants will receive bevacizumab 15 mg/kg on days 1,22, and 43.
  • Carboplatin — DRUG
    Participants 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 — DRUG
    Participants 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 Bevacizumab
    Participants 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)

FacilityCityStateZIPSite coordinators
Good Samaritan Cancer Care Center at Advocate Good Samaritan HospitalDowners GroveIllinois60515-1500-
Delnor Community Hospital - GenevaGenevaIllinois60134-4200-
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywoodIllinois60153-
Edward Hospital Cancer CenterNapervilleIllinois60540-
Swedish-American Regional Cancer CenterRockfordIllinois61104-2315-
Central Dupage Cancer CenterWinfieldIllinois60190-1295-

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