![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
Princess Margaret Hospital, Canada National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00509587 |
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.
PURPOSE: This phase II trial is studying how well giving pazopanib works in treating patients with recurrent or metastatic invasive breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: pazopanib hydrochloride Procedure: immunoenzyme technique Procedure: immunologic technique Procedure: laboratory biomarker analysis Procedure: pharmacological study |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of GW786034 (Pazopanib) in Patients With Recurrent and/or Metastatic Invasive Breast Carcinoma |
Estimated Enrollment: | 35 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, open label study.
Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and at 1, 4, and 8 weeks for correlative laboratory studies. Blood samples are evaluated for the following tumor markers by ELISA: VEGF, bFGF, sFLT-1, sTIE-2, sE-Selectin, VCAM-1, PDGF-AA, PDGF-AB and PDGF-BB. TSP-1 in plasma is measured by Accucyte^™ competitive immunoassay.
After completion of study treatment, patients are followed every 3 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed invasive breast carcinoma
Patients who may still benefit from hormonal therapy are ineligible
Patients with HER-2 positive disease who have not yet received trastuzumab (Herceptin^®) to maximal benefit are ineligible
PATIENT CHARACTERISTICS:
No poorly controlled hypertension (systolic blood pressure [BP] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)
No NYHA class III-IV heart failure
PRIOR CONCURRENT THERAPY:
No CYP2C9 substrates during or for 1-2 weeks after completion of study treatment, including any of the following:
Therapeutic warfarin
Canada, British Columbia | |
British Columbia Cancer Agency - Vancouver Cancer Centre | Recruiting |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Contact: Stephen Chia, MD 604-877-6000 | |
Canada, Ontario | |
Edmond Odette Cancer Centre at Sunnybrook | Recruiting |
Toronto, Ontario, Canada, M4N 3M5 | |
Contact: Kathleen I. Pritchard, MD 416-480-4616 kathy.pritchard@sunnybrook.ca | |
London Regional Cancer Program at London Health Sciences Centre | Recruiting |
London, Ontario, Canada, N6A 4L6 | |
Contact: Theodore A. Vandenberg, MD 519-685-8640 | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Natasha Leighl, MD, FRCPC 416-946-4645 | |
Ottawa Hospital Regional Cancer Centre - General Campus | Recruiting |
Ottawa, Ontario, Canada, K1H 8L6 | |
Contact: Susan F. Dent, MD 613-737-7700 ext. 70167 s.dent@ottawahospital.on.ca | |
Margaret and Charles Juravinski Cancer Centre | Recruiting |
Hamilton, Ontario, Canada, L8V 5C2 | |
Contact: Richard Tozer, MD, PhD 905-387-9495 ext. 64604 richard.tozer@hrcc.on.ca |
Study Chair: | Kathleen I. Pritchard, MD | Edmond Odette Cancer Centre at Sunnybrook |
Study ID Numbers: | CDR0000557347, PMH-PHL-057 |
Study First Received: | July 30, 2007 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00509587 |
Health Authority: | Unspecified |
stage IV breast cancer recurrent breast cancer male breast cancer |
Skin Diseases Breast Neoplasms, Male Breast Neoplasms |
Breast Diseases Recurrence Carcinoma |
Neoplasms Neoplasms by Site |