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Phase II Study of Carboplatin and Bevacizumab (Avastin) for ER Neg, PR Neg, and HER2/Neu Neg Metastatic Breast Cancer

This study is currently recruiting participants.
Verified by University of Chicago, April 2008

Sponsors and Collaborators: University of Chicago
Genentech
Information provided by: University of Chicago
ClinicalTrials.gov Identifier: NCT00517361
  Purpose

The purpose of this study is to determine the progression free survival (PFS) of metastatic ER, PR and HER2/neu negative breast cancers to the combination of carboplatin and bevacizumab (Avastin®) therapy.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: carboplatin
Drug: bevacizumab
Phase II

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

ChemIDplus related topics:   Carboplatin    Bevacizumab    Sodium chloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase II Study of Carboplatin and Bevacizumab (Avastin) Combination Therapy for ER Negative, PR Negative, and HER2/Neu Negative Metastatic Breast Cancer

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • progression free survival [ Time Frame: indefinite (subjects will be followed until disease progression) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response rate [ Time Frame: indefinite (subjects will be followed until disease progression) ] [ Designated as safety issue: No ]
  • duration of response [ Time Frame: indefinite (subjects will be followed until disease progression) ] [ Designated as safety issue: No ]
  • correlation of response to BRCA1 methylation status [ Time Frame: indefinite (subjects will be followed until disease progression) ] [ Designated as safety issue: No ]

Estimated Enrollment:   36
Study Start Date:   August 2007
Estimated Study Completion Date:   August 2009
Estimated Primary Completion Date:   August 2009 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: carboplatin
    AUC 6 in 250mL saline IV over 30 minutes
    Drug: bevacizumab
    15mg/kg in 100mL saline IV over 60 - 90 minutes
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients must have pathologically confirmed ER, PR and HER2/neu negative (FISH ratio of <2.0 or IHC <1+) metastatic breast cancer. Locally advanced or recurrent disease is also eligible.
  • Patients must have measurable disease
  • Patients must not have received prior chemotherapy for metastatic breast cancer (not including adjuvant therapy). Patients should be > 4 weeks from their most recent chemotherapy or radiation therapy treatment.
  • Age >18 years
  • ECOG performance status <1 (Karnofsky >80%).
  • Patients must have normal organ and marrow function as defined below:
  • absolute neutrophil count >1,500/uL
  • platelets >100,000/uL
  • total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SGPT) <2.5X institutional upper limit of normal
  • creatinine within normal institutional limits OR creatinine clearance>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  • PT INR < 1.5 (Unless patient is on anticoagulation)
  • urine protein <1+
  • Tissue from the primary tumor must be available for correlative studies
  • Women of child-bearing potential must agree to use adequate contraception
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who have had prior therapy with platinum agents or a VEGF inhibitor are not eligible.
  • Patients may not be receiving any other investigational agents.
  • Patients with known brain metastases will be excluded
  • Patients may have had prior radiation therapy, provided the patient has measurable disease and there has been clear progression since the completion of radiation therapy. Patients who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to therapy administered more than 4 weeks earlier will be excluded.
  • Patients with significant cardiac dysfunction will be excluded
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study, breastfeeding should be discontinued.
  • HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with carboplatin or the other agents administered during the study.
  • Patients with evidence of bleeding diathesis or coagulopathy.
  • Patients with inadequately controlled hypertension will be excluded
  • Patients who have had a stroke or TIA within 6 months of registration will be excluded.
  • Patients with a history of hypertensive crisis or hypertensive encephalopathy will be excluded.
  • Patients with a history of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months of registration.
  • Patient with history of serious non-healing wound, ulcer or bone fracture.
  • Patients with major surgery, open biopsy, or significant traumatic injury within 28 days of registration or anticipated need for surgery during course of study treatment.
  • Patients with a history core biopsy or other minor surgery, excluding venous access device (VAD) placement, within 7 days of registration.
  • Patients with active second malignancy.
  • Known hypersensitivity to any component of bevacizumab (Avastin®).
  • Peripheral neuropathy > Grade 1.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517361

Locations
United States, Illinois
University of Chicago     Recruiting
      Chicago, Illinois, United States, 60637
      Contact: Ezi Okafor     773-702-3936     eokafor@bsd.uchicago.edu    
      Principal Investigator: Rita Nanda, MD            
Oncology Specialists     Recruiting
      Park Ridge, Illinois, United States, 60068
      Contact: Philip Gozun     847-410-0662     pgozun@oncmed.net    
      Principal Investigator: Sigrun Hallmeyer, MD            

Sponsors and Collaborators
University of Chicago
Genentech

Investigators
Principal Investigator:     Rita Nanda, MD     University of Chicago    
  More Information


Responsible Party:   University of Chicago ( Rita Nanda, MD )
Study ID Numbers:   UCIRB 15578A
First Received:   August 14, 2007
Last Updated:   April 24, 2008
ClinicalTrials.gov Identifier:   NCT00517361
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Carboplatin
Bevacizumab
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
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008




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