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Weekly vs. Every 2 Week vs. Every 3 Week Administration of Abraxane/Bevacizumab Combination in Metastatic Breast Cancer
This study has been terminated.
( sufficient mature data to complete a final analysis )

First Received on January 24, 2006.   Last Updated on July 28, 2011   History of Changes
Sponsor: Celgene Corporation
Information provided by: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00281528
  Purpose

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 a 2-weekly regimen vs the standard 3-weekly infusion. All patients will also receive concurrent bevacizumab.


Condition Intervention Phase
Breast Neoplasms
Neoplasm Metastasis
Drug: ABI-007 (Abraxane) and Bevacizumab
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Confirmed Response Rate, Safety and Tolerability [ Time Frame: Percentage of patients who achieve an objective confirmed complete or partial overall lesion response measured every six weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival, duration of response, overall survival [ Time Frame: 24 Month Follow-Up. Percentage of patients with stable disease for >/- 16 weeks or complete or partial overall response ] [ Designated as safety issue: No ]

Enrollment: 212
Study Start Date: February 2006
Study Completion Date: March 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Every 3-week ABI-007 plus Bevacizumab
Drug: ABI-007 (Abraxane) and Bevacizumab
Treatment with various schedules ABI-007 and Bevacizumab
Experimental: 2
Every 2-week ABI-007 Plus Bevacizumab
Drug: ABI-007 (Abraxane) and Bevacizumab
Treatment with various schedules ABI-007 and Bevacizumab
Experimental: 3
Weekly ABI-007 plus Bevacizumab
Drug: ABI-007 (Abraxane) and Bevacizumab
Treatment with various schedules ABI-007 and Bevacizumab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  • ECOG performance status 0-2.
  • Female >18 years of age.
  • Patient has the following blood counts at Baseline:

ANC ≥ 1.5 x 10^9cells/L; platelets ≥ 100 x 10^9 cells/L; Hgb ≥ 9 g/dL.

  • Patient has the following blood chemistry levels at Baseline: AST SGOT), ALT (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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281528

  Show 40 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Principal Investigator: Andrew Seidman, MD Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Doria Schofield, Clinical Trials Manager, Abraxis BioScience
ClinicalTrials.gov Identifier: NCT00281528     History of Changes
Other Study ID Numbers: CA023
Study First Received: January 24, 2006
Last Updated: July 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
First Line Metastatic Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Paclitaxel
Bevacizumab
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012