Carboplatin, Paclitaxel, and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer

NCT00654836 | Completed Phase 2 Results

• 1 other identifier: 200027
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 6

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving carboplatin and paclitaxel together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel together with bevacizumab works in treating patients with locally recurrent or metastatic breast cancer.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage III breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Progression-free survival was measured from treatment initiation to 30 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  30 Months

Secondary Outcomes (2)

• Response Rate at End of Treatment

  30 Months

• Overall Survival

  80 Months

Study Arms (1)

Carboplatin, ABI-007 and Bevacizumab

EXPERIMENTAL

Participants will receive combination carboplatin, nanoparticle albumin-bound paclitaxel (ABI-007-Abraxane), and bevacizumab (Avastin)

Biological: bevacizumab; Drug: Carboplatin; Drug: ABI-007

Interventions

bevacizumab BIOLOGICAL

Participants will receive bevacizumab 15 mg/kg on days 1,22, and 43.

Also known as: Avastin

Carboplatin, ABI-007 and Bevacizumab

Carboplatin DRUG

Participants will receive a standard carboplatin dose according to their area under the plasma drug concentration-time curve (AUC-6) on days 1, 22, and 43.

Also known as: Paraplatin

Carboplatin, ABI-007 and Bevacizumab

ABI-007 DRUG

Participants will receive ABI-007 (Abraxane) 100mg/m2 on days 1,8, 15, 22, 29, 36,43,and 50.

Also known as: Abraxane

Carboplatin, ABI-007 and Bevacizumab

Eligibility Criteria

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

You may qualify if:

• Postmenopausal status not specified
• ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
• Life expectancy \> 12 weeks
• WBC ≥ 3,000/mcL
• Absolute neutrophil count ≥ 1,500/mcL
• Platelet count ≥ 100,000/mcL
• Total bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastasis is present in the absence of liver metastasis)
• Creatinine ≤ 1.5 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other concurrent malignancies within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

You may not qualify if:

• Pre-existing neuropathy ≥ grade 1
• Uncontrolled intercurrent illness including, but not limited to, any of the following:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Serious, non-healing wound, ulcer, or bone fracture
• Psychiatric illness/social situations that would limit compliance with study requirements
• Inadequately controlled hypertension (defined as systolic blood pressure \> 150 mm Hg and/or diastolic blood pressure \> 100 mm Hg on antihypertensive medications)
• History of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association class II-IV congestive heart failure
• History of myocardial infarction or unstable angina within the past 6 months
• History of stroke or transient ischemic attack within the past 6 months
• Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
• Symptomatic peripheral vascular disease

Sponsors & Collaborators

• Loyola University: lead
• Genentech, Inc.: collaborator
• Celgene Corporation: collaborator

Study Sites (6)

Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515-1500, United States

Location

Delnor Community Hospital - Geneva

Geneva, Illinois, 60134-4200, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Edward Hospital Cancer Center

Naperville, Illinois, 60540, United States

Location

Swedish-American Regional Cancer Center

Rockford, Illinois, 61104-2315, United States

Location

Central Dupage Cancer Center

Winfield, Illinois, 60190-1295, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Carboplatin; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins

Limitations and Caveats

There are no limitations or caveats to disclose.

Results Point of Contact

• Title: Shelly S. Lo, M.D.
• Organization: Loyola University

shlo@lumc.edu

708-327-3154

Study Officials

• Shelly Lo, MD

  Loyola University

  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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 9, 2008
• Study Start: October 1, 2007
• Primary Completion: February 1, 2012
• Study Completion: September 1, 2015
• Last Updated: September 14, 2017
• Results First Posted: September 14, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)