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
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