Pazopanib in Treating Patients With Recurrent or Metastatic Breast Cancer

NCT00509587 | Completed Phase 2 Results

• 5 other identifiers: NCI-2009-00199CDR0000557347PHL-0577638N01CM62203
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Partial and Complete Response.

  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

  Up to 3 years

Secondary Outcomes (5)

• Duration of Objective Response

  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

• Duration of Stable Disease

  From the start of the treatment until the criteria for progression are met, assessed up to 3 years

• Progression-free Survival

  6 months

• Overall Survival

  Up to 3 years

• Adverse Events Graded According to the NCI CTCAE Version 3.0

  Up to 3 years

Study Arms (1)

Treatment (pazopanib hydrochloride)

EXPERIMENTAL

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; Procedure: pharmacological study; Procedure: laboratory biomarker analysis

Interventions

pazopanib hydrochloride DRUG

Given orally

Also known as: GW786034B, Votrient

Treatment (pazopanib hydrochloride)

pharmacological study PROCEDURE

Correlative studies

Also known as: pharmacological studies

Treatment (pazopanib hydrochloride)

laboratory biomarker analysis PROCEDURE

Correlative studies

Treatment (pazopanib hydrochloride)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

The Ottawa Hospital Cancer Centre (Ottawa Health Research Institute) Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Natasha Leighl
• Organization: Princess Margaret Cancer Centre

natasha.leighl@uhn.ca

416-946-2399

Study Officials

• Natasha Leighl

  University Health Network-Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2007
• First Posted: July 31, 2007
• Study Start: June 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2013
• Last Updated: August 8, 2018
• Results First Posted: December 14, 2016

Record last verified: 2018-07

Locations

CA (3)