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Sutent Adjunctive Treatment of Differentiated Thyroid Cancer (IIT Sutent)

Primary Purpose

Papillary Thyroid Cancer, Follicular Thyroid Cancer, Differentiated Thyroid Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SU011248, Sutent
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Papillary Thyroid Cancer focused on measuring thyroid cancer, metastatic thyroid cancer, differentiated thyroid cancer, papillary thyroid cancer, follicular thyroid cancer, Histologically confirmed, metastatic stage 2,stage 3, or stage 4 differentiated thyroid cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The study population will consist of men and women with histologically confirmed stage 2 (younger than 45 years of age), 3 or stage 4 differentiated thyroid cancer (e.g., papillary or follicular thyroid cancer) that has been previously treated with at least one course of radioactive iodine therapy and has evidence of residual, recurrent or progressive disease documented by any combination of radiologic studies and thyroglobulin levels.

To be eligible for inclusion, patients must fulfill each of the following criteria:

  1. Provide written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
  2. Age >18 years.
  3. Histologically confirmed stage 2 (younger than 45 years of age), 3 or stage 4 differentiated thyroid cancer (i.e., papillary or follicular thyroid cancer).

    a. If a patient has distant metastases, it must be documented by any combination of radiographic studies or whole body radioiodine scanning.

  4. Previously treated with at least one course of radioactive iodine (I-131) therapy.
  5. At least one measurable site of disease as defined by the Tumor Assessment Criteria in Appendix 3.
  6. Serum thyroglobulin levels inappropriately elevated:

    > 60 ng/mL with thyroid gland > 1 ng/mL without thyroid gland

  7. ECOG performance status 0-2.
  8. Life expectancy ≥ 3 months.
  9. Normal organ function. The definitions of minimum adequacy for organ function required prior to study entry are as follows:

    1. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) less than or equal to 2.5 x upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy.
    2. Total serum bilirubin less than or equal to 1.5 x ULN.
    3. Serum albumin greater than or equal to 3.0 g/dL.
    4. Absolute neutrophil count (ANC) greater than or equal to 1500/uL.
    5. Platelets greater than or equal to 100,000/uL.
    6. Hemoglobin greater than or equal to 9.0 g/dL
    7. Serum creatinine less than or equal to 1.5 x ULN.
  10. Agreement to use contraceptives for women with child bearing potential. Unless surgically sterile, men must agree to use effective contraception during period of therapy.
  11. The patient must be aware of the nature of his or her malignancy, understand the protocol requirements, risks, discomforts, and be able and willing to sign an informed consent.

Exclusion Criteria:

Patients who fulfill any of the following criteria will be excluded:

  1. Prior systemic chemotherapy or targeted therapy within 3 months prior to enrollment.
  2. Prior treatment on a Sutent clinical trial or current treatment on another clinical trial.
  3. Prior external beam radiation therapy to the target lesion(s).
  4. Life expectancy < 3 months.
  5. History of any other carcinomas within the last 5 years, except cured basal cell carcinoma of the skin and cured in-situ cervical cancer.
  6. Serious uncontrolled concomitant disease that the Investigator feels might compromise study participation.
  7. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome, or the inability to take oral medication.
  8. Any of the following clinical conditions within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, pulmonary embolism, ongoing cardiac dysrhythmias of NCI CTCAE grade at least 2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females.
  9. Uncontrollable hypertension.
  10. Known human immunodeficiency virus infection.
  11. Current treatment with therapeutic doses of Coumadin-derivative anticoagulants (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
  12. Patients with a history of uncontrolled seizures, central nervous system disorders of psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded from study.
  13. Inability to swallow whole tablets.
  14. Unwillingness to participate or inability to comply with the protocol for the duration of the study.

Sites / Locations

  • MedStar Washington Hospital Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm - Sutent

Arm Description

Sutent 37.5 mg/day will be given orally.

Outcomes

Primary Outcome Measures

Progression Free Survival
Progressive disease (PD) is defined as unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions. Disease progression is accessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

Secondary Outcome Measures

Overall Survival
Overall survival is defined as the time from the start of treatment to the time to death from any cause or final data collection, whatever happens first.

Full Information

First Posted
April 25, 2008
Last Updated
August 3, 2020
Sponsor
Medstar Health Research Institute
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00668811
Brief Title
Sutent Adjunctive Treatment of Differentiated Thyroid Cancer
Acronym
IIT Sutent
Official Title
Sutent Adjunctive Treatment of Differentiated Thyroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is comparing a drug called Sutent with standard of care treatment for people with advanced thyroid cancer. Because advanced thyroid cancer is becoming increasingly common and effective treatment options are limited, new therapies are desperately needed. This study is designed to see if Sutent following therapy with radioactive iodine will target cancer cells and delay disease progression better than standard therapy alone. Newly diagnosed patients, who are scheduled to receive radioactive iodine as part of their standard care are possible candidates. By entering into this study, participants agree to take oral Sutent for approximately two years after completing standard therapy. During this time, study participants will be followed closely by their doctor.
Detailed Description
This is a two-stage, phase II, single center, targeted therapy trial enrolling patients with stage 2 (for patients younger than 45 years of age), 3 or 4 differentiated thyroid cancer. The primary objective is to assess progression free survival in this population. Sutent will be given orally at 37.5mg daily for two (2) year, or 26 cycles. Each treatment cycle will consist of 28 days. Upon treatment discontinuation, patients will be followed for survival. The frequency and type of survival follow-up assessments performed will be at the discretion of the treating physician.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillary Thyroid Cancer, Follicular Thyroid Cancer, Differentiated Thyroid Cancer
Keywords
thyroid cancer, metastatic thyroid cancer, differentiated thyroid cancer, papillary thyroid cancer, follicular thyroid cancer, Histologically confirmed, metastatic stage 2,stage 3, or stage 4 differentiated thyroid cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm - Sutent
Arm Type
Experimental
Arm Description
Sutent 37.5 mg/day will be given orally.
Intervention Type
Drug
Intervention Name(s)
SU011248, Sutent
Other Intervention Name(s)
Sunitinib
Intervention Description
Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles.
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Progressive disease (PD) is defined as unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions. Disease progression is accessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Time Frame
12 months after last patient completes treatment
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival is defined as the time from the start of treatment to the time to death from any cause or final data collection, whatever happens first.
Time Frame
12 months after last patient completes treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The study population will consist of men and women with histologically confirmed stage 2 (younger than 45 years of age), 3 or stage 4 differentiated thyroid cancer (e.g., papillary or follicular thyroid cancer) that has been previously treated with at least one course of radioactive iodine therapy and has evidence of residual, recurrent or progressive disease documented by any combination of radiologic studies and thyroglobulin levels. To be eligible for inclusion, patients must fulfill each of the following criteria: Provide written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. Age >18 years. Histologically confirmed stage 2 (younger than 45 years of age), 3 or stage 4 differentiated thyroid cancer (i.e., papillary or follicular thyroid cancer). a. If a patient has distant metastases, it must be documented by any combination of radiographic studies or whole body radioiodine scanning. Previously treated with at least one course of radioactive iodine (I-131) therapy. At least one measurable site of disease as defined by the Tumor Assessment Criteria in Appendix 3. Serum thyroglobulin levels inappropriately elevated: > 60 ng/mL with thyroid gland > 1 ng/mL without thyroid gland ECOG performance status 0-2. Life expectancy ≥ 3 months. Normal organ function. The definitions of minimum adequacy for organ function required prior to study entry are as follows: Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) less than or equal to 2.5 x upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy. Total serum bilirubin less than or equal to 1.5 x ULN. Serum albumin greater than or equal to 3.0 g/dL. Absolute neutrophil count (ANC) greater than or equal to 1500/uL. Platelets greater than or equal to 100,000/uL. Hemoglobin greater than or equal to 9.0 g/dL Serum creatinine less than or equal to 1.5 x ULN. Agreement to use contraceptives for women with child bearing potential. Unless surgically sterile, men must agree to use effective contraception during period of therapy. The patient must be aware of the nature of his or her malignancy, understand the protocol requirements, risks, discomforts, and be able and willing to sign an informed consent. Exclusion Criteria: Patients who fulfill any of the following criteria will be excluded: Prior systemic chemotherapy or targeted therapy within 3 months prior to enrollment. Prior treatment on a Sutent clinical trial or current treatment on another clinical trial. Prior external beam radiation therapy to the target lesion(s). Life expectancy < 3 months. History of any other carcinomas within the last 5 years, except cured basal cell carcinoma of the skin and cured in-situ cervical cancer. Serious uncontrolled concomitant disease that the Investigator feels might compromise study participation. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome, or the inability to take oral medication. Any of the following clinical conditions within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, pulmonary embolism, ongoing cardiac dysrhythmias of NCI CTCAE grade at least 2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females. Uncontrollable hypertension. Known human immunodeficiency virus infection. Current treatment with therapeutic doses of Coumadin-derivative anticoagulants (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed). Patients with a history of uncontrolled seizures, central nervous system disorders of psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded from study. Inability to swallow whole tablets. Unwillingness to participate or inability to comply with the protocol for the duration of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth D Burman, MD
Organizational Affiliation
Medstar Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17505827
Citation
Britten CD, Kabbinavar F, Hecht JR, Bello CL, Li J, Baum C, Slamon D. A phase I and pharmacokinetic study of sunitinib administered daily for 2 weeks, followed by a 1-week off period. Cancer Chemother Pharmacol. 2008 Mar;61(3):515-24. doi: 10.1007/s00280-007-0498-4. Epub 2007 May 16.
Results Reference
background
PubMed Identifier
26671977
Citation
Bikas A, Kundra P, Desale S, Mete M, O'Keefe K, Clark BG, Wray L, Gandhi R, Barett C, Jelinek JS, Wexler JA, Wartofsky L, Burman KD. Phase 2 clinical trial of sunitinib as adjunctive treatment in patients with advanced differentiated thyroid cancer. Eur J Endocrinol. 2016 Mar;174(3):373-80. doi: 10.1530/EJE-15-0930. Epub 2015 Dec 15.
Results Reference
result

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Sutent Adjunctive Treatment of Differentiated Thyroid Cancer

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