Phase II Trial of Doxil, Carboplatin, Bevacizumab in Triple Negative Untreated Metastatic Breast Cancer

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Completed

CT.gov ID

NCT00608972

Collaborator

Rutgers Cancer Institute of New Jersey (Other), National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

Duration (Months)

7.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer	Drug: Doxil Drug: Carboplatin Drug: Bevacizumab	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Doxil, Carboplatin and Bevacizumab	Drug: Doxil Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle. Drug: Carboplatin Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle. Drug: Bevacizumab Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle. Other Names: Avastin

Arm

Intervention/Treatment

Experimental: Doxil, Carboplatin and Bevacizumab

Drug: Doxil

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

Drug: Carboplatin

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

Drug: Bevacizumab

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

Other Names:

Avastin

Outcome Measures

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. [2 years]

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 [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Cooper Hospital/University Medical Center	Camden	New Jersey	United States	08103
2	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey	United States	08690
3	Saint Peter's University Hospital	New Brunswick	New Jersey	United States	08901
4	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903