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Pazopanib in Treating Patients With Recurrent or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00509587
Recruitment Status : Completed
First Posted : July 31, 2007
Results First Posted : December 14, 2016
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This phase II trial is studying how well giving pazopanib works in treating patients with recurrent or metastatic invasive breast cancer. 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer Drug: pazopanib hydrochloride Procedure: pharmacological study Procedure: laboratory biomarker analysis Phase 2

Detailed Description:

PRIMARY OBJECTIVE:

I. 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 OBJECTIVES:

I. To determine the duration of objective response, rate and duration of stable disease.

II. To determine 6-month progression-free and median and overall survival rates in patients treated with this drug.

III. 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of GW786034 (Pazopanib) in Patients With Recurrent and/or Metastatic Invasive Breast Carcinoma
Study Start Date : June 2007
Primary Completion Date : July 2009
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Treatment (pazopanib hydrochloride)
Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: pazopanib hydrochloride
Given orally
Other Names:
  • GW786034B
  • Votrient
Procedure: pharmacological study
Correlative studies
Other Name: pharmacological studies
Procedure: laboratory biomarker analysis
Correlative studies


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Partial and Complete Response. [ Time Frame: Up to 3 years ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT / MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR


Secondary Outcome Measures :
  1. Duration of Objective Response [ Time Frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years ]
  2. Duration of Stable Disease [ Time Frame: From the start of the treatment until the criteria for progression are met, assessed up to 3 years ]
  3. Progression-free Survival [ Time Frame: 6 months ]
    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions

  4. Overall Survival [ Time Frame: Up to 3 years ]
    Computed using the Kaplan-Meier method.

  5. Adverse Events Graded According to the NCI CTCAE Version 3.0 [ Time Frame: Up to 3 years ]
    grade 3- 4 toxicities - transaminitis, hypertension, and neutropenia in three patients each (14% each) and grade 3 gastrointestinal hemorrhage in one patient (5%).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Criteria:

  • No prior bevacizumab
  • 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
  • ECOG performance status (PS) 0-1 or Karnofsky PS 60-100%
  • Life expectancy > 12 weeks
  • 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)
  • 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
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy, or surgery
  • No cardiac angioplasty or stenting within the last 12 weeks
  • No more than 1 prior chemotherapy regimen for recurrent disease
  • No prior surgical procedures affecting absorption
  • 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

  • No CYP2C9 substrates during or for 1-2 weeks after completion of study treatment, including any of the following:

    • 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 CYP2C9 substrates during or for 1-2 weeks after completion of study treatment, including any of the following:

    • Oral hypoglycemics: glipizide, glyburide, or tolbutamide
    • Ergot derivatives: dihydroergotamine, ergonovine, ergotamine, or methylergonovine
    • Neuroleptics: pimozide
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • WBC >= 3,000/mm³
  • No more than 2 prior palliative systemic chemotherapy regimens for de novo metastatic disease
  • Creatinine normal OR creatinine clearance >= 60 mL/min
  • At least 3 months since prior trastuzumab
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509587


Locations
Canada, British Columbia
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
The Ottawa Hospital Cancer Centre (Ottawa Health Research Institute) Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Natasha Leighl University Health Network-Princess Margaret Hospital
More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00509587     History of Changes
Other Study ID Numbers: NCI-2009-00199
NCI-2009-00199 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000557347
PHL-057
PHL-057 ( Other Identifier: University Health Network-Princess Margaret Hospital )
7638 ( Other Identifier: CTEP )
N01CM62203 ( U.S. NIH Grant/Contract )
First Posted: July 31, 2007    Key Record Dates
Results First Posted: December 14, 2016
Last Update Posted: December 14, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases