Selumetinib in Treating Patients With Papillary Thyroid Cancer That Did Not Respond to Radioactive Iodine

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Brief Title

Selumetinib in Treating Patients With Papillary Thyroid Cancer That Did Not Respond to Radioactive Iodine

Official Title

Phase 2 Study of Selumetinib Hydrogen Sulfate in Iodine-131 Refractory Papillary Thyroid Carcinoma and Papillary Thyroid Carcinoma With Follicular Elements

Brief Summary

      This phase II trial is studying how well selumetinib works in treating patients with
      papillary thyroid cancer that did not respond to radioactive iodine. Selumetinib may stop the
      growth of tumor cells by blocking some of the enzymes needed for cell growth.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. Ascertain the objective response rate (complete response and partial response) in patients
      with iodine I 131-refractory papillary thyroid cancer treated with selumetinib.

      SECONDARY OBJECTIVES:

      I. Determine the toxicity of this treatment in these patients. II. Determine the
      pharmacokinetic profile of this treatment in these patients. III. Determine the
      progression-free and overall survival of these patients. IV. Assess proxy measures of
      treatment response (thyroglobulin and PET scan) in patients treated with selumetinib.

      IV. Compare relevant laboratory correlates between responders and non-responders.

      OUTLINE: This is a multicenter study.

      Patients receive oral selumetinib twice daily on days 1-28. Treatment repeats every 28 days
      in the absence of unacceptable toxicity or disease progression.

      Archived tissue is examined for gene mutations, including RET, BRAF, NTRK, and RAS, by
      fluorescence in situ hybridization and/or polymerase chain reaction and fluorescence melting
      curve analysis. Protein expression of ERK and phosphorylated ERK is assessed by
      immunohistochemical staining.

      Blood samples are collected periodically for pharmacokinetic analysis and biomarker
      assessment (thyroglobulin and antithyroglobulin autoantibodies).

      After completion of study therapy, patients are followed periodically for up to 2 years.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Objective Response Rate (ORR)

Secondary Outcome

 Median Progression-Free Survival (PFS)

Condition

Recurrent Thyroid Gland Carcinoma

Intervention

Laboratory Biomarker Analysis

Study Arms / Comparison Groups

 Arm I
Description:  Patients receive oral selumetinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.

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

39

Start Date

December 2007

Completion Date

August 2016

Primary Completion Date

August 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed papillary thyroid cancer or papillary
             thyroid cancer with follicular elements

          -  No longer amenable to radioactive iodine therapy or curative surgical resection

               -  Tumor is no longer iodine avid

               -  Tumor did not respond to the most recent radioactive iodine treatment

               -  Patient is ineligible for further radioactive iodine therapy due to medical
                  contraindications (e.g., lung toxicity)

          -  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 CT scan

          -  Evidence of disease progression (objective growth of existing tumors)

               -  New or enlarging measurable lesions within the past 12 months

               -  If the most recent imaging study is older than 12 months, patients will still be
                  eligible if objectively measurable disease progression is associated with
                  clinical symptoms

          -  Archival tumor tissue available for mutational analysis

          -  No known brain metastases

          -  ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

          -  Life expectancy > 12 weeks

          -  WBC ≥ 3,000/µL

          -  ANC ≥ 1,500/µL

          -  Platelet count ≥ 100,000/µL

          -  Total bilirubin normal

          -  AST and ALT < 2.5 times upper limit of normal

          -  Creatinine normal OR creatinine clearance ≥ 60 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception prior to, during, and for 4 weeks
             after completion of study treatment

          -  Able to understand and willing to sign a written informed consent document

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to selumetinib (AZD6244) or its excipient Captisol®

          -  QTc interval > 450 msec or other factors that increase the risk of QT prolongation

          -  Arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT
             interval syndrome), including heart failure that meets NYHA class III and IV
             definition

          -  Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory
             bowel disease), or significant bowel resection that would preclude adequate absorption

          -  Concurrent uncontrolled illness including, but not limited to, ongoing or active
             infection or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  At least 4 weeks since prior radiotherapy or chemotherapy (6 weeks for nitrosoureas or
             mitomycin C)

          -  Prior treatment with tyrosine kinase inhibitors that target RET or RAF

          -  Prior treatment with MEK inhibitors

          -  Concurrent combination antiretroviral therapy for HIV-positive patients

          -  Concurrent medication that can prolong the QT interval

          -  Other concurrent investigational agents
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

David Neil Hayes, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00559949

Organization ID

NCI-2009-01056

Secondary IDs

NCI-2009-01056

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

David Neil Hayes, Principal Investigator, UNC Lineberger Comprehensive Cancer Center


Verification Date

December 2016