Phase II Trial of Doxil, Carboplatin, Bevacizumab in Triple Negative Untreated Metastatic Breast Cancer
This study is currently recruiting participants.
Verified June 2012 by University of Medicine and Dentistry New Jersey
Sponsor:
University of Medicine and Dentistry New Jersey
Collaborator:
Cancer Institute of New Jersey
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00608972
First received: January 23, 2008
Last updated: June 12, 2012
Last verified: June 2012
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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 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 2014 |
| Estimated Primary Completion Date: | June 2014 (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:
- 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 | |
| Cooper Hospital/University Medical Center | Recruiting |
| Camden, New Jersey, United States, 08103 | |
| Contact: Robert Somer, MD 856-325-6740 robert@cooperhealth.edu | |
| Principal Investigator: Robert Somer, MD | |
| The Cancer Institute of New Jersey at Hamilton | Recruiting |
| Hamilton, New Jersey, United States, 08690 | |
| Contact: Michael Eleff, MD 609-631-6946 | |
| Principal Investigator: Michael Eleff, MD | |
| Cancer Institute of New Jersey (CINJ) | Recruiting |
| New Brunswick, New Jersey, United States, 08902 | |
| Contact: Deborah Toppmeyer, MD 732-235-8675 | |
| Principal Investigator: Deborah Toppmeyer, MD | |
| Saint Peter's University Hospital | Terminated |
| New Brunswick, New Jersey, United States, 08901 | |
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
Additional Information:
No publications provided
| Responsible Party: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00608972 History of Changes |
| Other Study ID Numbers: | 040702, NJ 2107, IRB# 0220070274 |
| Study First Received: | January 23, 2008 |
| Last Updated: | June 12, 2012 |
| 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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Doxorubicin Bevacizumab Carboplatin Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013