Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer

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Brief Title

Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer

Official Title

A Phase II Study of GW 786034 (Pazopanib) in Advanced Thyroid Cancer

Brief Summary

      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.
    

Detailed Description

      PRIMARY OBJECTIVE:

      I. To establish the safety and efficacy of GW786034 (pazopanib hydrochloride) as a
      therapeutic in patients afflicted with differentiated, medullary and anaplastic thyroid
      cancers.

      CORRELATIVE OBJECTIVES:

      I. Assessment of the impact of therapy with GW786034 on serum/plasma vascular endothelial
      growth factor (VEGF) levels.

      II. To explore the potential relationship between changes in thyroglobulin levels and tumor
      response in patients with advanced differentiated thyroid cancer known to be thyroglobulin
      antibody negative.

      OUTLINE:

      Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Cycles
      repeat every 28 days in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 6 months for up to 3
      years after registration.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall Response Rate (in Cohorts 1-3)

Secondary Outcome

 Toxicity as Measured by the Percentage of Patients Reporting a Grade 3+ Adverse Event Deemed Possibly, Probably, or Definitely Related to Treatment

Condition

Recurrent Thyroid Gland Carcinoma

Intervention

Laboratory Biomarker Analysis

Study Arms / Comparison Groups

 Cohort 1 (DTC)
Description:  Patients with differentiated thyroid cancer (DTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

152

Start Date

February 22, 2008

Completion Date

August 13, 2019

Primary Completion Date

December 21, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  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)

        Exclusion Criteria:

          -  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)

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection or psychiatric illness/social situations that would or might reasonably be
             expected to limit compliance with study requirements

          -  Pregnant women; NOTE: (breastfeeding should be discontinued if the mother is treated
             with GW786034/pazopanib)

          -  Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
             therapy; NOTE: (appropriate studies will be undertaken in patients receiving
             combination antiretroviral therapy when indicated)

          -  Receiving any medications or substances known to affect or with the potential to
             affect the activity or pharmacokinetics of GW786034 (pazopanib); NOTE: the eligibility
             of patients will be determined following review of their case by the principal
             investigator; efforts should be made to switch patients who are taking enzyme-inducing
             anticonvulsant agents to other medications

          -  Receiving any concomitant medications that are associated with a risk of QTc
             prolongation and/or Torsades de Pointes; NOTE: these medications should be
             discontinued or replaced with drugs that do not carry these risks, if possible
      

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Keith C Bible, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT00625846

Organization ID

NCI-2009-00198

Secondary IDs

NCI-2009-00198

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Keith C Bible, Principal Investigator, Mayo Clinic


Verification Date

February 2020