Phase II Trial of Doxil, Carboplatin, Bevacizumab in Triple Negative Untreated Metastatic Breast Cancer - Full Text View

Purpose

The purpose of this research study is to look at the effectiveness of a combination of doxil, carboplatin and bevacizumab on metastatic breast cancer. The type of breast cancer being studied is negative for a protein called HER2/neu and for estrogen receptors (ER) and progesterone receptors (PR). HER2/neu, ER and PR are part of a family of receptors found on both cancer and normal cells. This family of receptors is important for cell growth and is found in many tumor types.This study is being conducted for the following research purposes:· To find out what effects, if any, the study drug has on metastatic breast cancer. For instance, will the study drug cause the tumor(s) to shrink or stop growing?· To test the safety of the study drugs and to see what affects it has. For instance, are there any side effects? If so, what kind of side effects does the study drug cause? How severe are the side effects, and how often do they occur?· To see if the study drugs have any effect on keeping the disease from getting worse.

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: Doxil Drug: Carboplatin Drug: Bevacizumab	Phase II

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

Drug Information available for:

Doxorubicin Doxorubicin hydrochloride Carboplatin Bevacizumab Progesterone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase II Trial of Doxil, Carboplatin and Bevacizumab in Triple Negative Previously Untreated Metastatic Breast Cancer

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

The primary objective of this study is to determine the median progression free survival (PFS) and 1-year PFS after treatment with doxil, carboplatin and bevacizumab in patients with ER, PR, HER2neu negative metastatic breast cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

determine response rate (as determined by RECIST criteria) to combination therapy with doxil, carboplatin and bevacizumab in patients with metastatic breast cancer. determine toxicity of combination therapy with doxil, carboplatin, and bevac [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle.

Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle.

Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women with previously untreated metastatic breast cancer, ER/PR/HER2/neu negative.
Age >= 18
ECOG performance status <= 2
Normal organ and marrow function
Normal cardiac function as evidenced by LVEF within institutional normal limits

Exclusion Criteria:

History of hypersensitivity reactions to doxil or bevacizumab
Myocardial infarct or unstable angina within 6 months before enrollment
Prior anthracycline dose exceeding 360 mg/m2 for doxorubicin (including DOXIL) or 720 mg/m2 for epirubicin.
Proteinuria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608972

Contacts


Contact: Deborah Toppmeyer, MD	732-235-9692	toppmede@umdnj.edu

Contact: Lien Huzzy, RN, BSN, OCN	732-235-8962	tanglb@umdnj.edu

Locations


United States, New Jersey
	Cancer Institute of New Jersey (CINJ)	Recruiting
	New Brunswick, New Jersey, United States, 08902
	Principal Investigator: Deborah Toppmeyer, MD

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

Cancer Institute of New Jersey

Investigators


Principal Investigator:	Deborah Toppmeyer, MD	UMDNJ/CINJ

More Information

Responsible Party:	UMDNJ/CINJ ( Deborah Toppmeyer, MD )
Study ID Numbers:	040702, NJ 2107, IRB# 0220070274
First Received:	January 23, 2008
Last Updated:	February 5, 2008
ClinicalTrials.gov Identifier:	NCT00608972
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:

negative for a protein called HER2/neu

negative for estrogen receptors (ER) and progesterone receptors (PR).

breast cancer

Study placed in the following topic categories:

Progesterone

Skin Diseases

Breast Neoplasms

Carboplatin

Bevacizumab

Doxorubicin

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Antineoplastic Agents

Growth Substances

Therapeutic Uses

Physiological Effects of Drugs

Growth Inhibitors

Angiogenesis Modulating Agents

Antibiotics, Antineoplastic

Angiogenesis Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 03, 2008

Sponsors and Collaborators:	University of Medicine and Dentistry New Jersey Cancer Institute of New Jersey
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00608972