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

Information source: Celgene Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Neoplasms; Neoplasm Metastasis

Intervention: ABI-007 (Abraxane) (Drug); bevacizumab (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Celgene Corporation

Official(s) and/or principal investigator(s):
Andrew Seidman, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

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.

Clinical Details

Official title: A Phase II Study of Weekly Versus Every 2-week Versus Every 3-week Administration of ABI-007 (Abraxane) in Combination With Bevacizumab in Women With Metastatic Breast Cancer.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

The Percentage of Participants Confirmed Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0)

Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)

Participant Counts of the Most Severe Grade for White Blood Cells (WBC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)

Participant Counts of the Most Severe Grade for Platelet Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)

Participant Counts of the Most Severe Grade for Hemoglobin Levels as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)

The Number of Participants With at Least One Dose Reduction for ABI-007

The Number of Participants With at Least One Dose Delay for ABI-007

The Number of Participants With a Dose Interruption of ABI-007

Secondary outcome:

Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response (i.e., Total Response) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0)

Kaplan Meier Estimate for Time to Disease Progression (TTP)

Kaplan Meier Estimate for Duration of Response

Kaplan Meier Estimate for Participant Survival

Kaplan Meier Estimate for Progression-Free Survival (PFS)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

Metropolitan Oncology Center, San Juan, Puerto Rico

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 06610, United States

Palm Beach Institute of Hematology and Oncology, Boynton Beach, Florida, United States

Memorial Cancer Institute/Breast Cancer Center, Hollywood, Florida 33021, 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 30281, 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 01960, 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

Additional Information

Starting date: February 2006
Last updated: March 19, 2012

Page last updated: August 23, 2015

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