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Sponsors and Collaborators: |
UNC Lineberger Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00232505 |
RATIONALE: Monoclonal antibodies, such as cetuximab, 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. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving cetuximab together with carboplatin is more effective than giving cetuximab alone in treating metastatic breast cancer.
PURPOSE: This randomized phase II trial is studying cetuximab and carboplatin to see how well they work compared with cetuximab alone in treating women with estrogen receptor-negative (ER-), progesterone receptor-negative (PR-) metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: carboplatin Drug: cetuximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Phase II Trial of Cetuximab Alone and in Combination With Carboplatin in ER-Negative, PR-Negative, HER-2 Nonoverexpressing Metastatic Breast Cancer |
Estimated Enrollment: | 100 |
Study Start Date: | November 2005 |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.
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Drug: cetuximab
Given IV
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Arm II: Experimental
Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
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Drug: carboplatin
Given IV
Drug: cetuximab
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment in arm I may cross over to arm II.
Blood samples are collected periodically throughout study for correlative biomarker analysis by IHC and gene expression analysis.
After completion of study treatment, patients are followed every 4 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Measurable disease by RECIST criteria
HER2 nonoverexpressing disease by IHC (0 or 1) or non-gene amplified by FISH
Hormone receptor status:
PATIENT CHARACTERISTICS:
No significant history of uncontrolled cardiac disease including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No more than 3 prior chemotherapy regimens either in the adjuvant or metastatic setting
Concurrent bisphosphonates allowed
United States, Alabama | |
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
United States, District of Columbia | |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
Washington, District of Columbia, United States, 20007 | |
Washington Cancer Institute at Washington Hospital Center | |
Washington, District of Columbia, United States, 20010 | |
United States, Indiana | |
Indiana University Melvin and Bren Simon Cancer Center | |
Indianapolis, Indiana, United States, 46202-5289 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599-7295 | |
Rex Cancer Center at Rex Hospital | |
Raleigh, North Carolina, United States, 27607 | |
United States, Texas | |
Baylor University Medical Center - Houston | |
Houston, Texas, United States, 77030 | |
M. D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 |
Principal Investigator: | Lisa A. Carey, MD | UNC Lineberger Comprehensive Cancer Center |
Responsible Party: | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill ( Lisa A. Carey ) |
Study ID Numbers: | CDR0000549855, UNC-LCCC-0403 |
Study First Received: | October 3, 2005 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00232505 |
Health Authority: | United States: Federal Government |
recurrent breast cancer stage IV breast cancer |
Progesterone Skin Diseases Cetuximab Breast Neoplasms |
Carboplatin Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |