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Sponsored by: |
Loyola University |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00654836 |
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.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: bevacizumab Drug: carboplatin Drug: paclitaxel albumin-stabilized nanoparticle formulation Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Carboplatin, Nanoparticle Albumin-Bound Paclitaxel (ABI-007) and Avastin as the First Line Therapy in Metastatic Breast Cancer. |
Estimated Enrollment: | 72 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive carboplatin IV over 1 hour and bevacizumab IV on days 1, 22 and 43. Patients also receive paclitaxel albumin-bound nanoparticle formulation IV over 30 minutes on days 1, 8 ,15, 22, 29, 36, 43, and 50. Treatment continues in the absence of disease progression or unacceptable toxicity.
Formalin-fixed paraffin-embedded archived tumor tissue samples are assessed by IHC for various biomarkers. Levels of Notch-1, Notch-4, cyclin A, cyclin B, Jagged-1, and DLL4 in tumor-associated endothelial cells are correlated with response in both estrogen- and progesterone-positive and negative tumors, and independently of p53 status.
After completion of study treatment, patients are followed for up to 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary adenocarcinoma of the breast
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Uncontrolled intercurrent illness including, but not limited to, any of the following:
Proteinuria, as demonstrated by either urine protein:creatinine ratio ≥ 1.0 OR urine dipstick for proteinuria ≥ 2+
PRIOR CONCURRENT THERAPY:
Concurrent anticoagulation allowed, provided the following criteria are met:
United States, Illinois | |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Recruiting |
Maywood, Illinois, United States, 60153 | |
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center 708-226-4357 | |
Central Dupage Cancer Center | Recruiting |
Winfield, Illinois, United States, 60190-1295 | |
Contact: Contact Person 630-933-5281 | |
Delnor Community Hospital - Geneva | Recruiting |
Geneva, Illinois, United States, 60134-4200 | |
Contact: Contact Person 630-208-4563 | |
Swedish-American Regional Cancer Center | Recruiting |
Rockford, Illinois, United States, 61104-2315 | |
Contact: Contact Person 815-489-4113 | |
Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital | Recruiting |
Downers Grove, Illinois, United States, 60515-1500 | |
Contact: Contact Person 630-369-1501 | |
Edward Hospital Cancer Center | Recruiting |
Naperville, Illinois, United States, 60540 | |
Contact: Contact Person 630-646-6072 |
Principal Investigator: | Shelly Lo, MD | Loyola University |
Study ID Numbers: | CDR0000593048, LUMC-LU200027, ABRAXIS-LU200027 |
Study First Received: | April 8, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00654836 |
Health Authority: | Unspecified |
recurrent breast cancer stage III breast cancer stage IV breast cancer |
Skin Diseases Paclitaxel Breast Neoplasms Carboplatin |
Bevacizumab Breast Diseases Recurrence |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |