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

NCT00517361 | Terminated Phase 2 Results DMC

• 1 other identifier: 15578A
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

  Up to 5 years

Secondary Outcomes (3)

• Response Rate

  Up to 5 years

• Duration of Response

  Up to 5 years

• Correlation of Response to BRCA1 Methylation Status

  Up to 5 years

Study Arms (1)

Carboplatin + Avastin

EXPERIMENTAL

Drug: carboplatin; Drug: bevacizumab

Interventions

carboplatin DRUG

AUC 6 in 250mL saline IV over 30 minutes

Carboplatin + Avastin

bevacizumab DRUG

15mg/kg in 100mL saline IV over 60 - 90 minutes

Also known as: Avastin

Carboplatin + Avastin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• Genentech, Inc.: collaborator

Study Sites (2)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Oncology Specialists

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Carboplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Rita Nanda
• Organization: The University of Chicago

rnanda@medicine.bsd.uchicago.edu

773-834-2756

Study Officials

• Rita Nanda, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2007
• First Posted: August 16, 2007
• Study Start: August 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2012
• Last Updated: April 15, 2014
• Results First Posted: April 15, 2014

Record last verified: 2014-03

Locations

US (2)