Sutent Adjunctive Treatment of Differentiated Thyroid Cancer

NCT00668811

Last updated date
Study Location
MedStar Washington Hospital Center
Washington, District of Columbia, 20010, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Papillary Thyroid Cancer, Follicular Thyroid Cancer, Differentiated Thyroid Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Papillary Thyroid Cancer, Follicular Thyroid Cancer, Differentiated Thyroid CancerSutent Adjunctive Treatment of Differentiated Thyroid Cancer
NCT00668811
  1. Washington, District of Columbia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Sutent Adjunctive Treatment of Differentiated Thyroid Cancer
Official Title  ICMJE Sutent Adjunctive Treatment of Differentiated Thyroid Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Papillary Thyroid Cancer
  • Follicular Thyroid Cancer
  • Differentiated Thyroid Cancer
Intervention  ICMJE Drug: SU011248, Sutent
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.
Other Name: Sunitinib
Study Arms  ICMJE Experimental: Treatment Arm - Sutent
Sutent 37.5 mg/day will be given orally.
Intervention: Drug: SU011248, Sutent
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2014)
23
Original Estimated Enrollment  ICMJE
 (submitted: April 25, 2008)
43
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00668811
Other Study ID Numbers  ICMJE WCI-2007-214
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medstar Health Research Institute
Study Sponsor  ICMJE Medstar Health Research Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Kenneth D Burman, MDMedstar Health Research Institute
PRS Account Medstar Health Research Institute
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP