Docetaxel,Carboplatin,Trastuzumab and Bevacizumab for Breast Cancer and Bone Marrow Micrometastases

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT00949247
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
    Bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, treatment modifications may apply according to response.
  • trastuzumab — BIOLOGICAL
    Trastuzumab IV over 30-90 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, treatment modifications may apply according to response.
  • carboplatin — DRUG
    Carboplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, treatment modifications may apply according to response.
  • docetaxel — DRUG
    Docetaxel IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, treatment modifications may apply according to response.
  • laboratory biomarker analysis — OTHER
    Tumor tissue and bone marrow samples may be collected for further laboratory analysis.

Study Details

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, 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 trastuzumab and 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 tumor-killing substances to them. Giving chemotherapy together with monoclonal antibody therapy may kill more tumor cells. PURPOSE: This clinical trial is studying how well giving docetaxel and carboplatin together with trastuzumab and bevacizumab works in treating patients with stage I, stage II, or stage III breast cancer and bone marrow micrometastases.

Key Dates

First listed
Jul 30, 2009
Start date
Dec 31, 2009
Status verified
Jul 2020
Primary completion
Jan 31, 2013
Completion
Jan 31, 2013

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Docetaxel,Carboplatin,Trastuzumab and Bevacizumab

Primary Outcome Measure

Proportion of patients who have a complete response in bone marrow. [ Time Frame: at 4 weeks after completing 6 courses of therapy ]

Locations (5)

FacilityCityStateZIPSite coordinators
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44106-
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterClevelandOhio44195-
University Hospitals MonarchMayfield HeightsOhio44124-
University Hospitals Chagrin Highlands Medical CenterOrangeOhio44122-
University Hospitals WestlakeWestlakeOhio44145-

Find similar trials in Cleveland, OH

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center· Cleveland, OHCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center· Cleveland, OHUniversity Hospitals Monarch· Mayfield Heights, OHUniversity Hospitals Chagrin Highlands Medical Center· Orange, OHUniversity Hospitals Westlake· Westlake, OH

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