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Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450879 |
RATIONALE: Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving pazopanib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This clinical trial is studying how well pazopanib works in treating patients with newly diagnosed stage II or stage III breast cancer that can be removed by surgery.
Condition | Intervention |
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Breast Cancer |
Drug: pazopanib hydrochloride Procedure: biopsy Procedure: conventional surgery Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: gene expression profiling Procedure: immunohistochemistry staining method Procedure: immunologic technique Procedure: laboratory biomarker analysis Procedure: neoadjuvant therapy Procedure: pharmacological study Procedure: protein expression analysis |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Pilot Study of GW786034 (Pazopanib), a Vascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitor, in Patients With Operable Breast Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, pilot study.
Patients receive oral pazopanib hydrochloride once daily for 12-20 days. Patients then undergo surgical resection of tumor between days 13 and 21 (24 hours after completion of pazopanib hydrochloride).
Patients undergo dynamic contrast-enhanced MRI at baseline, on day 2 or 3, and at 24-72 hours prior to surgery. Blood samples are collected periodically for analysis of circulating endothelial cells and pharmacokinetic studies. Patients also undergo tumor biopsy at baseline and at the time of surgery. Samples are analyzed by immunohistochemistry, microarray (gene expression profiling), and TUNEL assays to assess vascular endothelial growth factor (VEGF), VEGF receptor-2 (VEGFR-2), epidermal growth factor receptor (EGFR), MAPK, AKT, phosphorylated (p) VEGFR-2, pEGFR, pMAPK, and pAKT activity, tumor cell proliferation (Ki67) and apoptosis, and microvessel density (using endothelial markers CD31 [PECAM-1], CD34, and CD 133).
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer by core-needle biopsy
Measurable disease by physical exam or ultrasound
Able to undergo surgical treatment with either lumpectomy or mastectomy
PATIENT CHARACTERISTICS:
No condition that would inhibit ability to swallow and retain oral medications, including the following:
No history of any of the following within the past 12 months:
PRIOR CONCURRENT THERAPY:
No concurrent therapeutic warfarin
United States, New Jersey | |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
New Brunswick, New Jersey, United States, 08903 | |
Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 |
Study Chair: | Antoinette R. Tan, MD | Cancer Institute of New Jersey |
Study ID Numbers: | CDR0000534258, CINJ-040607, CINJ-GW786034 |
Study First Received: | March 20, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00450879 |
Health Authority: | Unspecified |
male breast cancer stage II breast cancer stage IIIA breast cancer |
Skin Diseases Breast Neoplasms, Male Breast Neoplasms Endothelial Growth Factors Breast Diseases |
Neoplasms Neoplasms by Site |