IIT Sutent: Sutent Adjunctive Treatment of Differentiated Thyroid Cancer

• Sponsor: Medstar Health Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00668811
• Collaborator: Pfizer (Industry)
• Enrollment: 23
• Location: 1
• Arm: 1
• Duration (Months): 92
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Papillary Thyroid Cancer; Follicular Thyroid Cancer; Differentiated Thyroid Cancer	Drug: SU011248, Sutent	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sutent Adjunctive Treatment of Differentiated Thyroid Cancer
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Treatment Arm - Sutent Sutent 37.5 mg/day will be given orally.

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 Names: Sunitinib

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival [12 months after last patient completes treatment]

   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

1. Overall Survival [12 months after last patient completes treatment]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

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

1. Previously treated with at least one course of radioactive iodine (I-131) therapy.

2. At least one measurable site of disease as defined by the Tumor Assessment Criteria in Appendix 3.

3. Serum thyroglobulin levels inappropriately elevated:

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

1. ECOG performance status 0-2.

2. Life expectancy ≥ 3 months.

3. Normal organ function. The definitions of minimum adequacy for organ function required prior to study entry are as follows:

4. 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.

5. Total serum bilirubin less than or equal to 1.5 x ULN.

6. Serum albumin greater than or equal to 3.0 g/dL.

7. Absolute neutrophil count (ANC) greater than or equal to 1500/uL.

8. Platelets greater than or equal to 100,000/uL.

9. Hemoglobin greater than or equal to 9.0 g/dL

10. Serum creatinine less than or equal to 1.5 x ULN.

11. Agreement to use contraceptives for women with child bearing potential. Unless surgically sterile, men must agree to use effective contraception during period of therapy.

12. 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.

1. Uncontrollable hypertension.

2. Known human immunodeficiency virus infection.

3. 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).

4. 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.

5. Inability to swallow whole tablets.

6. Unwillingness to participate or inability to comply with the protocol for the duration of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010

Sponsors and Collaborators

• Medstar Health Research Institute
• Pfizer

Investigators

• Principal Investigator: Kenneth D Burman, MD, Medstar Health Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Epub 2007 May 16.

• Responsible Party: Medstar Health Research Institute
• ClinicalTrials.gov Identifier: NCT00668811
• Other Study ID Numbers: WCI-2007-214
• First Posted: Apr 29, 2008
• Last Update Posted: Aug 5, 2020
• Last Verified: Aug 1, 2020

• Keywords provided by Medstar Health Research Institute: 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
• Additional relevant MeSH terms: Thyroid Neoplasms; Thyroid Cancer, Papillary; Adenocarcinoma, Follicular; Thyroid Diseases; Sunitinib

Study Results

Participant Flow

Arm/Group Title	Treatment Arm - Sutent
Arm/Group Description	Sutent 37.5 mg/day will be given orally. 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.
Period Title: Overall Study
STARTED	23
COMPLETED	23
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment Arm - Sutent
Arm/Group Description	Sutent 37.5 mg/day will be given orally. 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.
Overall Participants	23
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	61
Sex: Female, Male (Count of Participants)
Female	6 26.1%
Male	17 73.9%
Region of Enrollment (Count of Participants)
United States	23 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm - Sutent
Arm/Group Description	Sutent 37.5 mg/day will be given orally. 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.
Measure Participants	23
Median (Inter-Quartile Range) [days]	241

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm - Sutent
Arm/Group Description	Sutent 37.5 mg/day will be given orally. 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.
Measure Participants	23
Median (Inter-Quartile Range) [days]	1694

Adverse Events

Arm/Group Title	Treatment Arm - Sutent
Arm/Group Description	Sutent 37.5 mg/day will be given orally. 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.
All Cause Mortality
	Treatment Arm - Sutent
	Affected / at Risk (%)	# Events
Total	23/23 (100%)
Serious Adverse Events
	Treatment Arm - Sutent
	Affected / at Risk (%)	# Events
Total	2/23 (8.7%)
Gastrointestinal disorders
Bowel Obstruction	1/23 (4.3%)	2
Rectal bleeding	1/23 (4.3%)	1
Other (Not Including Serious) Adverse Events
	Treatment Arm - Sutent
	Affected / at Risk (%)	# Events
Total	23/23 (100%)
Blood and lymphatic system disorders
Leukopenia	19/23 (82.6%)
Thrombocytopenia	13/23 (56.5%)
Anemia	11/23 (47.8%)
Neutropenia	15/23 (65.2%)
Lymphopenia	5/23 (21.7%)
Cardiac disorders
Hypertension	6/23 (26.1%)
Gastrointestinal disorders
Diarrhea	12/23 (52.2%)
Anorexia	7/23 (30.4%)
Constipation	7/23 (30.4%)
Heartburn	4/23 (17.4%)
Hemorrhoids	3/23 (13%)
Mucostitis	5/23 (21.7%)
Nausea	9/23 (39.1%)
Taste Alteration	9/23 (39.1%)
Vomiting	8/23 (34.8%)
GI Hemorrage	4/23 (17.4%)
GI Pain	6/23 (26.1%)
Nuerological Pain	6/23 (26.1%)
General disorders
Fatigue	12/23 (52.2%)
General Pain	5/23 (21.7%)
Infections and infestations
Infection	4/23 (17.4%)
Metabolism and nutrition disorders
Increased Alkaline Phosphate	4/23 (17.4%)
Increased ALT	11/23 (47.8%)
Increased AST	11/23 (47.8%)
Increased creatinine	10/23 (43.5%)
Hypoalbuminemia	7/23 (30.4%)
Hypocalcemia	10/23 (43.5%)
Hypoglycemia	3/23 (13%)
Hypokalemia	4/23 (17.4%)
Hyponatremia	6/23 (26.1%)
Proteinuria	5/23 (21.7%)
Musculoskeletal and connective tissue disorders
Muscoskeletal Pain	9/23 (39.1%)
Respiratory, thoracic and mediastinal disorders
Pulmonary	4/23 (17.4%)
Cough	8/23 (34.8%)
Dyspnea	8/23 (34.8%)
Skin and subcutaneous tissue disorders
Hand-foot Syndrome	9/23 (39.1%)
Hypopigmentation	3/23 (13%)
Rash	4/23 (17.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.