Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Pazopanib in Treating Patients With Recurrent or Metastatic Breast Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008
Sponsors and Collaborators: Princess Margaret Hospital, Canada
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00509587
  Purpose

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

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Pazopanib Pazopanib Hydrochloride
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Antitumor activity, in terms of objective response rates [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of objective response, rate and duration of stable disease [ Designated as safety issue: No ]
  • 6-month progression-free and median and overall survival rates [ Designated as safety issue: No ]
  • Safety and tolerability [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: June 2007
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the antitumor activity of pazopanib, in terms of objective response rate (partial and complete response), in patients with recurrent or metastatic invasive breast cancer.

Secondary

  • To determine the duration of objective response, rate and duration of stable disease.
  • To determine 6-month progression-free and median and overall survival rates in patients treated with this drug.
  • To document the safety and tolerability of this drug in these patients.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed invasive breast carcinoma

    • Recurrent or metastatic disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
  • Patients who may still benefit from hormonal therapy are ineligible

    • Patients with hormone receptor-positive breast cancer should have received appropriate sequential hormonal therapy for metastatic disease until disease progression
  • Patients with HER-2 positive disease who have not yet received trastuzumab (Herceptin^®) to maximal benefit are ineligible

    • Patients with disease progression during trastuzumab therapy are eligible
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-1 or Karnofsky PS 60-100%
  • Life expectancy > 12 weeks
  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelets ≥ 100,000/mm³
  • Total bilirubin normal (exception made for patients with known Gilbert's disease)
  • AST/ALT ≤ 2.5 times upper limit of normal (ULN)
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • No proteinuria > +1 on two consecutive dipsticks taken ≥ 1 week apart
  • PT/INR/PTT ≤ 1.2 times ULN
  • No allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib or other study agents
  • No QTc prolongation (defined as a QTc interval ≥ 500 msecs) or other significant ECG abnormalities
  • No condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, or active peptic ulcer disease) that would impair ability to swallow and retain study drug
  • No poorly controlled hypertension (systolic blood pressure [BP] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)

    • Initiation or adjustment of BP medication is allowed prior to study entry provided that the average of 3 BP readings prior to study entry is < 140/90 mm Hg
  • No serious or non-healing wound, ulcer, or bone fracture
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the last 4 weeks
  • No cerebrovascular accident within the last 6 months
  • No myocardial infarction, cardiac arrhythmia, hospital admission for unstable angina within the last 12 weeks
  • No venous thrombosis within the last 12 weeks
  • No NYHA class III-IV heart failure

    • Patients with a history of class II heart failure may be considered eligible provided they are asymptomatic on treatment
  • No concurrent uncontrolled illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would preclude study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy, or surgery
  • At least 3 months since prior trastuzumab
  • No cardiac angioplasty or stenting within the last 12 weeks
  • No more than 1 prior chemotherapy regimen for recurrent disease
  • No more than 2 prior palliative systemic chemotherapy regimens for de novo metastatic disease
  • No prior surgical procedures affecting absorption
  • No prior bevacizumab
  • No CYP2C9 substrates during or for 1-2 weeks after completion of study treatment, including any of the following:

    • Therapeutic warfarin

      • Low molecular weight heparin or prophylactic low-dose warfarin are allowed
    • Oral hypoglycemics: glipizide, glyburide, or tolbutamide
    • Ergot derivatives: dihydroergotamine, ergonovine, ergotamine, or methylergonovine
    • Neuroleptics: pimozide
    • Erectile dysfunction agents: sildenafil, tadalafil, or vardenafil
    • Antiarrhythmics: bepridil, flecainide, lidocaine, mexilitine, amiodarone, or quinidine
    • Immune modulators: cyclosporine, tacrolimus, or sirolimus
    • Miscellaneous: theophylline, quetiapine, or risperidone
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509587

Locations
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    
Sponsors and Collaborators
Princess Margaret Hospital, Canada
Investigators
Study Chair: Kathleen I. Pritchard, MD Edmond Odette Cancer Centre at Sunnybrook
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
male breast cancer

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms, Male
Breast Neoplasms
Breast Diseases
Recurrence
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009