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

Part of paid clinical trials in Camden, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT00608972
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Doxil — DRUG
    Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
  • Carboplatin — DRUG
    Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
  • Bevacizumab — DRUG
    Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.

Study Details

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.

Key Dates

First listed
Feb 6, 2008
Start date
May 16, 2008
Status verified
Feb 2023
Primary completion
Jul 12, 2015
Completion
Sep 25, 2015

Study Design

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

Arms

  • Experimental: Doxil, Carboplatin and Bevacizumab

Primary Outcome Measure

Progression Free Survival (PFS) After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative Metastatic Breast Cancer [ Time Frame: Two Years ]

Locations (7)

FacilityCityStateZIPSite coordinators
Cooper Hospital/University Medical CenterCamdenNew Jersey08103-
Cancer Institute of New Jersey at HamiltonHamiltonNew Jersey08690-
Morristown Medical CenterMorristownNew Jersey07960-
Jersey Shore University Medical CenterNeptune CityNew Jersey07753-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Saint Peter's University HospitalNew BrunswickNew Jersey08901-
Overlook Medical CenterSummitNew Jersey07901-

Find similar trials in Camden, NJ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Cooper Hospital/University Medical Center· Camden, NJCancer Institute of New Jersey at Hamilton· Hamilton, NJMorristown Medical Center· Morristown, NJJersey Shore University Medical Center· Neptune City, NJRutgers Cancer Institute of New Jersey· New Brunswick, NJSaint Peter's University Hospital· New Brunswick, NJ

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