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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00608972
First received: January 23, 2008
Last updated: September 18, 2014
Last verified: September 2014
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Doxil, Carboplatin and Bevacizumab in Triple Negative Previously Untreated Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of 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: May 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    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 Name: Avastin
  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  1. History of hypersensitivity reactions to doxil or bevacizumab
  2. Myocardial infarct or unstable angina within 6 months before enrollment
  3. Prior anthracycline dose exceeding 360 mg/m2 for doxorubicin (including DOXIL) or 720 mg/m2 for epirubicin.
  4. Proteinuria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New Jersey
Cooper Hospital/University Medical Center
Camden, New Jersey, United States, 08103
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Rutgers Cancer Institute of New Jersey
Investigators
Principal Investigator: Deborah Toppmeyer, MD Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00608972     History of Changes
Other Study ID Numbers: 040702, NJ 2107, Pro0220070274, P30CA072720, NCI-2012-00524
Study First Received: January 23, 2008
Last Updated: September 18, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
negative for a protein called HER2/neu
negative for estrogen receptors (ER) and progesterone receptors (PR).
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Bevacizumab
Carboplatin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014