Weekly vs. Every 2 Week vs. Every 3 Week Administration of ABI-007 (Abraxane)/Bevacizumab Combination in Metastatic Breast Cancer

NCT ID: NCT00281528

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-01
• Study Completion Date: 2011-03-01

Brief Summary

This is a multi-center, open-label, randomized Phase II study in previously untreated patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense ABI-007 (Abraxane) compared to 2-weekly regimen vs the standard 3-weekly infusion. All patients will also receive concurrent bevacizumab.

Conditions

Breast Neoplasms; Neoplasm Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

260 mg/m^2 ABI-007 every 3 weeks

260 mg/m\^2 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks

Group Type: EXPERIMENTAL

ABI-007 (Abraxane)

Intervention Type: DRUG

30 minute infusions

bevacizumab

Intervention Type: DRUG

infusions

260 mg/m^2 ABI-007 every 2 weeks

260 mg/m\^2 ABI-007 every 2 weeks and 10 mg/kg bevacizumab every 2 weeks

Group Type: EXPERIMENTAL

ABI-007 (Abraxane)

Intervention Type: DRUG

30 minute infusions

bevacizumab

Intervention Type: DRUG

infusions

130 mg/m^2 ABI-007 weekly

130 mg/m\^2 ABI-007 weekly (without a week of 'rest') and 10 mg/kg bevacizumab every 2 weeks

Group Type: EXPERIMENTAL

ABI-007 (Abraxane)

Intervention Type: DRUG

30 minute infusions

bevacizumab

Intervention Type: DRUG

infusions

Interventions

ABI-007 (Abraxane)

30 minute infusions

Intervention Type: DRUG

bevacizumab

infusions

Intervention Type: DRUG

Other Intervention Names

Abraxane; paclitaxel bound to albumin; Avastin

Eligibility Criteria

Inclusion Criteria

• Pathologically confirmed adenocarcinoma of the breast.
• Stage IV disease
• Measurable disease
• Patients must not be a candidate for Herceptin therapy
• At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease within the radiation portal.
• At least 4 weeks since major surgery, with full recovery.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Female >18 years of age.
• Patient has the following blood counts at Baseline:

Absolute neutrophil count ≥ 1.5 x 10^9cells/L; platelets ≥ 100 x 10^9 cells/L; hemoglobin ≥ 9 g/dL.

• Patient has the following blood chemistry levels at Baseline: Aspartate transaminase (AST or SGOT), alanine aminotransferase (ALT or SGPT) ≤ 2.5x upper limit of normal range (ULN); total bilirubin ≤ ULN; creatinine ≤ 1.5 mg/dL.
• If female of childbearing potential, pregnancy test is negative within 72 hours of first dose of study drug.
• If fertile, the patient agrees to use an effective method to avoid pregnancy for the duration of the study.
• Informed consent has been obtained.

Exclusion Criteria

• Prior neo-adjuvant or adjuvant chemotherapy is allowed, and patients must have recovered from the acute toxicity of such therapies. No prior therapy for metastatic disease is allowed. If a taxane was part of the adjuvant regimen, at least 12 months should have passed from completion of taxane regimen to relapse. If a non-taxane-based adjuvant therapy was administered, at least 6 months should have passed from completion to relapse.
• Concurrent immunotherapy or hormonal therapy.
• Parenchymal brain metastases, including leptomeningeal involvement.
• Inadequately controlled hypertension (defined as blood pressure of > 150/100 mmHg) or New York Heart Association (NYHA) Grade 2 or greater congestive heart failure.
• Any prior history of hypertensive crisis or hypertensive encephalopathy.
• History of myocardial infarction or unstable angina within 6 months prior to study enrollment.
• History of stroke or transient ischemic attack within 6 months prior to study enrollment.
• Significant vascular disease (e.g., aortic aneurysm, aortic dissection).
• Symptomatic peripheral vascular disease.
• Evidence of bleeding diathesis or coagulopathy.
• History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 6 months prior to study enrollment.
• Proteinuria at screening as demonstrated by either: - Urine protein:creatinine (UPC) ratio > 1.0 at screening OR - Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
• Known hypersensitivity to any component of bevacizumab.
• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to first dose.
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to first dose, anticipation of need for major surgical procedure during the course of the study. Serious, non-healing wound, ulcer, or bone fracture. Serious intercurrent medical or psychiatric illness, including serious active infection.
• History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
• Pregnant or nursing women.
• Sensory neuropathy of > Grade 1 at baseline.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Seidman, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Division of Hematology/Oncology University of Alabama at Birmingham

Birmingham, Alabama, United States

Little Rock Hematology Oncology Associates

Little Rock, Arkansas, United States

California Oncology of the Central Valley

Fresno, California, United States

Glendale Memorial Hospital & Health Center

Glendale, California, United States

Front Range Cancer Specialists

Fort Collins, Colorado, United States

Oncology Associates of Bridgeport

Bridgeport, Connecticut, United States

Palm Beach Institute of Hematology and Oncology

Boynton Beach, Florida, United States

Memorial Cancer Institute/Breast Cancer Center

Hollywood, Florida, United States

Florida Cancer Institute

Hudson, Florida, United States

Hematology Oncology Associates

Lake Worth, Florida, United States

Medical Specialist of the Palm Beaches, Inc

Lake Worth, Florida, United States

Gulfcoast Oncology Associates

St. Petersburg, Florida, United States

Peachtree Hematology & Oncology Associates

Atlanta, Georgia, United States

Northwest Georgia Oncology Centers, PC

Marietta, Georgia, United States

Center of Hope for Cancers and Blood

Stockbridge, Georgia, United States

Maine Center for Cancer Medicine & Blood Disorders

Scarborough, Maine, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Harbor View Cancer Center

Baltimore, Maryland, United States

Boston Medical Center Moakley Building, Solomont Center for Hematology & Medical Oncology

Boston, Massachusetts, United States

North Shore Medical Cancer Center

Peabody, Massachusetts, United States

St. John's Mercy Medical Center

St Louis, Missouri, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Drs. Forte, Schleidere, & Attas, PA

Englewood, New Jersey, United States

Saint Barnabas Medical Center

Livingston, New Jersey, United States

Monmouth Medical Center

Long Branch, New Jersey, United States

Rosewell Park Cancer Institute Elm & Carlton Carlton Building

Buffalo, New York, United States

Beth Israel Comprehensive Cancer Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

NYU Clinical Cancer Center

New York, New York, United States

Marion L. Shepard Cancer Center

Washington, North Carolina, United States

Medical Oncology Aultman Hospital

Canton, Ohio, United States

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, United States

Abington Hematology Oncology

Willow Grove, Pennsylvania, United States

Family Cancer Center

Collierville, Tennessee, United States

Tennessee Cancer Specialists

Knoxville, Tennessee, United States

TX Oncology, PA

Austin, Texas, United States

South Texas Oncology & Hematology Clinical Research Dept.

San Antonio, Texas, United States

Virginia Commonwealth University Medical Oncology

Richmond, Virginia, United States

Swedish Cancer Institute

Seattle, Washington, United States

Metropolitan Oncology Center

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

References

Seidman AD, Conlin AK, Bach A, Moynahan ME, Lake D, Forero A, Wright GS, Hackney MH, Clawson A, Norton L, Hudis CA. Randomized phase II trial of weekly vs. every 2 weeks vs. every 3 weeks nanoparticle albumin-bound paclitaxel with bevacizumab as first-line chemotherapy for metastatic breast cancer. Clin Breast Cancer. 2013 Aug;13(4):239-246.e1. doi: 10.1016/j.clbc.2013.02.008.

Reference Type: BACKGROUND

PMID: 23829890 (View on PubMed)

Conlin AK, Seidman AD, Bach A, Lake D, Dickler M, D'Andrea G, Traina T, Danso M, Brufsky AM, Saleh M, Clawson A, Hudis CA. Phase II trial of weekly nanoparticle albumin-bound paclitaxel with carboplatin and trastuzumab as first-line therapy for women with HER2-overexpressing metastatic breast cancer. Clin Breast Cancer. 2010 Aug 1;10(4):281-7. doi: 10.3816/CBC.2010.n.036.

Reference Type: RESULT

PMID: 20705560 (View on PubMed)

Other Identifiers

CA023

Identifier Type: -

Identifier Source: org_study_id