Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer

Completed · Phase 2

Conditions studied: Recurrent Thyroid Gland Carcinoma, Stage III Differentiated Thyroid Gland Carcinoma AJCC v7, Stage III Thyroid Gland Medullary Carcinoma AJCC v7, Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v7, Stage IVA Thyroid Gland Anaplastic Carcinoma AJCC v7, Stage IVA Thyroid Gland Medullary Carcinoma AJCC v7, Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v7, Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v7, Stage IVB Thyroid Gland Medullary Carcinoma AJCC v7, Stage IVC Differentiated Thyroid Gland Carcinoma AJCC v7, Stage IVC Thyroid Gland Anaplastic Carcinoma AJCC v7, Stage IVC Thyroid Gland Medullary Carcinoma AJCC v7, Thyroid Gland Anaplastic Carcinoma

In brief

This phase II trial studies the side effects and how well pazopanib hydrochloride works in treating patients with advanced thyroid cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by stopping blood flow to the tumor.

Key facts

Study ID

NCT00625846

Run by

National Cancer Institute (NCI)

People needed

152

Starts

2008-02-22

Expected to finish

2019-08-13

Last updated by the study team

2020-02-26

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed differentiated, medullary or anaplastic thyroid cancer that is now advanced or metastatic; NOTE: patients with thyroid lymphomas or sarcomas are specifically excluded, as are patients with metastatic disease from other sites of origin to thyroid
• Patients with confirmed differentiated thyroid cancer to be enrolled in the expanded/additional differentiated thyroid cancer (DTC) cohort must be thyroglobulin antibody negative
• Zero, one or two prior therapeutic regimens (this includes cytotoxic plus non-cytotoxic therapeutic regimens)
• Absence of sensitivity to therapeutic radioiodine (differentiated only)
• Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan; NOTE: disease that is measurable by physical examination only is not eligible
• Life expectancy > 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 (Karnofsky >= 60%)
• Leukocytes > 3,000/mcL obtained =< 7 days prior to registration
• Absolute neutrophil count > 1,500/mcL obtained =< 7 days prior to registration
• Platelets > 100,000/mcL obtained =< 7 days prior to registration
• Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) obtained =< 7 days prior to registration (if there is reason to believe that the patient has Gilbert's syndrome, the bilirubin can be fractionated; if the fractionated bilirubin is consistent with Gilbert's syndrome and there is no other possible explanation for the elevated indirect bilirubin, the patient may be eligible for the study if and only if the direct bilirubin is =< 1.5 X institutional ULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) < 2.5 X institutional ULN obtained =< 7 days prior to registration
• Creatinine =< 1.5 X ULN obtained =< 7 days prior to registration
• Proteinuria =< + on urinalysis (may re-check) obtained =< 7 days prior to registration
• International normalized ratio (INR) =< 1.2 X the ULN obtained =< 7 days prior to registration
• Blood pressure (BP) < 140 mmHg (systolic) and < 90 mmHg (diastolic); initiation or adjustment of BP medication is permitted prior to registration provided that the average of three BP readings at a visit prior to registration is < 140/90 mmHg
• Objective evidence of tumor progression in the 6 month period prior to GW786034 initiation as assessed by:
• Unequivocal progression of objectively measured disease on successive appropriate imaging (e.g. CT scan); in cases of uncertainty of tumor progression, the principal investigator of the study will be available to assist in decisions
• Women of child-bearing potential must have a negative serum pregnancy test =< 7 days prior to registration; NOTE: women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; effective contraception is required for all fertile participants in the trial
• Ability to understand and the willingness to sign a written informed consent document
• Willingness to comply with the requirement of the study
• Willingness to donate blood for correlative marker studies; (only applicable to sites within the United States)

You may not qualify if…

• Anaplastic, differentiated, medullary: a total of > 2 prior therapeutic regimens (this total includes cytotoxic plus non-cytotoxic regimens); Note: enrollment of anaplastic, differentiated, and medullary patients who have had zero, one or two prior therapeutic regimens (cytotoxic plus non-cytotoxic regimens) is allowed - provided therapy ceased > 21 days prior to registration;
• NOTE: the principal investigator of the study should be contacted in the event of uncertainty related patient eligibility based upon prior therapies
• Disease that is measurable by physical examination only
• Any of the following:
• Radiotherapy =< 4 weeks prior to registration
• Major surgery =< 4 weeks prior to registration
• Radiotherapy to >= 25% of bone marrow
• Concurrent therapy with octreotide unless tumor progression on this therapy has been demonstrated
• Any other ongoing investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW786034 (pazopanib) or other agents used in the study
• > +1 proteinuria (< 30 mg/dL) on two consecutive dipstick or other urine assessments taken at least 1 week apart; NOTE: (in cases where questions arise related to disparate proteinuria measurements, the study principal investigator [PI] should be consulted for assistance in determining patient study eligibility)
• Corrected QT interval (QTc) prolongation (defined as a QTc interval >= 480 msecs) or other significant electrocardiogram (ECG) abnormalities (e.g. frequent ventricular ectopy, evidence of ongoing myocardial ischemia); NOTE: the principal investigator of the study should be contacted in the event of uncertainty related patient eligibility based upon ECG changes
• Receiving cytochrome P450 (CYP) interactive concomitant medications; certain medications that act through the CYP450 system are specifically prohibited in patients receiving GW786034 (pazopanib) because in vitro data indicate that the agent has the potential to interact with the cytochrome P450 isoenzymes cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) and cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); certain other agents should be used with caution
• Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain GSK786034 (pazopanib)
• Any of the following conditions:
• Serious or non-healing wound, ulcer, or bone fracture
• History of abdominal fistula, gastrointestinal perforation, active diverticulitis, intra-abdominal abscess or gastrointestinal tract bleeding =< 28 days of registration
• Any history of cerebrovascular accident (CVA) =< 6 months
• Current use of therapeutic warfarin; Note: low molecular weight heparin and prophylactic low-dose warfarin (INR < 1.2 X ULN) are permitted; prothrombin time (PT)/partial thromboplastin time (PTT) must meet the inclusion criteria
• History of myocardial infarction, cardiac arrhythmia, admission for unstable angina, cardiac angioplasty or stenting within the last 12 weeks
• History of venous thrombosis in last 12 weeks
• Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; NOTE: a patient who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible
• History of bleeding disorder, including patients afflicted with hemophilia, disseminated intravascular coagulation, or any other abnormality of coagulation potentially predisposing patients to bleeding
• Poorly controlled depression or anxiety disorder, or recent (=< 6 months) suicidal ideation
• Known active and/or untreated brain metastases and/or brain metastases requiring ongoing therapy (e.g. corticosteroids); NOTE: (because of the poor prognosis often associated with brain metastases and because of the potential risk of bleeding in active brain metastases associated with multi-targeted tyrosine kinase inhibitor therapy, patients with active and/or untreated brain metastases and/or those with brain metastases requiring ongoing therapy - e.g. corticosteroids - are excluded from trial enrollment; enrollment will, however, be permitted in cases of patients with longstanding treated and inactive brain metastases not requiring ongoing therapy, providing that stability of brain metastases has been demonstrated for a period of 3 months or greater as assessed by intracranial imaging - and providing that there is no indication of increased vascularity of the treated metastases by magnetic resonance imaging (MRI) imaging conducted =< 14 days prior to registration; when questions arise related to these criteria, the PI of the trial, Dr. Keith Bible, should be contacted for assistance on eligibility)

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
• Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
• Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States
• Fairview Ridges Hospital — Burnsville, Minnesota, United States
• Fairview-Southdale Hospital — Edina, Minnesota, United States
• Unity Hospital — Fridley, Minnesota, United States
• Minnesota Oncology Hematology PA-Maplewood — Maplewood, Minnesota, United States
• Abbott-Northwestern Hospital — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Park Nicollet Clinic - Saint Louis Park — Saint Louis Park, Minnesota, United States
• United Hospital — Saint Paul, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
• Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
• Chinese University of Hong Kong-Prince of Wales Hospital — Shatin, Hong Kong, China
• National University Hospital Singapore — Singapore, Singapore
• National Cancer Centre — Singapore, Singapore
• Johns Hopkins Singapore — Singapore, Singapore
• National Taiwan University Hospital — Taipei, Taiwan

Full record on ClinicalTrials.gov

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