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Tanespimycin in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT00118248
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : May 6, 2014
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Thyroid Cancer
Stage IV Follicular Thyroid Cancer
Stage IV Papillary Thyroid Cancer
Thyroid Gland Medullary Carcinoma
Intervention Drug: tanespimycin
Enrollment 41
Recruitment Details

From February 2005 thru April 2009, 41 participants were accrued to the this study.

The study was closed to enrollment in July, 2009 due to a slow accrual rate.

Pre-assignment Details From February 2005 thru February 2009, 17 participants were accrued to the Advanced Medullary Thyroid Carcinoma group. From February 2008 thru April 2009, 24 participants were accrued to the Differentiated Thyroid Carcinoma group.
Arm/Group Title Advanced Medullary Thyroid Carcinoma Group Differentiated Thyroid Carcinoma
Hide Arm/Group Description Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 17 24
Completed 17 24
Not Completed 0 0
Arm/Group Title Advanced Medullary Thyroid Carcinoma Group Differentiated Thyroid Carcinoma Total
Hide Arm/Group Description Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 17 24 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants 24 participants 41 participants
56
(33 to 70)
61
(34 to 80)
60
(33 to 80)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 24 participants 41 participants
Female
5
  29.4%
11
  45.8%
16
  39.0%
Male
12
  70.6%
13
  54.2%
25
  61.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 24 participants 41 participants
17 24 41
1.Primary Outcome
Title Proportion of Patients Who Have Remained on Treatment and Progression-free at Least One Year After Start of 17-AAG (Tanespimycin)
Hide Description

The one-year treatment failure free rate is 100% times the proportion of eligible patients who remain on treatment and are progression-free at least one year after treatment start. A 90% confidence interval for the one year treatment failure free rate was constructed using the properties of the binomial confidence interval.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are not classified as having a progression are termed progression-free.

Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients were evaluable for this endpoint in this group.
Arm/Group Title Advanced Medullary Thyroid Carcinoma Group Differentiated Thyroid Carcinoma
Hide Arm/Group Description:
Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 17 24
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
5.9
(0.3 to 25.0)
12.5
(3.5 to 29.2)
2.Secondary Outcome
Title Overall Response
Hide Description

The number of responses were categorized and summarized independently within each of the patient groups. Participants were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.0.

Complete Response (CR): Disappearance of all lesions.

Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD.

Time Frame Baseline, every 3 courses, and at the end of treatment study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants were evaluated for response.
Arm/Group Title Advanced Medullary Thyroid Carcinoma Group Differentiated Thyroid Carcinoma
Hide Arm/Group Description:
Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 17 24
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 0 0
Partial Response (PR) 1 0
3.Secondary Outcome
Title Progression-Free Survival
Hide Description Defined as the time from registration to the date of progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are not classified as having a progression are termed progression-free. Estimated using the Kaplan-Meier method.
Time Frame Every 3 months for up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants were evaluable for this endpoint.
Arm/Group Title Advanced Medullary Thyroid Carcinoma Group Differentiated Thyroid Carcinoma
Hide Arm/Group Description:
Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 17 24
Median (95% Confidence Interval)
Unit of Measure: months
6.4
(2.7 to 17.2)
4.1
(2.2 to 8.7)
4.Secondary Outcome
Title Overall Survival
Hide Description Defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the Kaplan-Meier method.
Time Frame Every 3 months until progression, and then every 6 months up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients were evaluable for this endpoint.
Arm/Group Title Advanced Medullary Thyroid Carcinoma Group Differentiated Thyroid Carcinoma
Hide Arm/Group Description:
Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 17 24
Median (95% Confidence Interval)
Unit of Measure: years
2.1
(0.67 to 3.1)
1.5
(0.73 to 3.5)
5.Secondary Outcome
Title Toxicity
Hide Description Defined as the number of participants reporting grade 3 or higher adverse events that are classified as either possibly, probably, or definitely related to study treatment. Determined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time Frame Every 3 courses during treatment (median cycle number was 5 with a maximum of 38 cycles)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants were evaluable for this endpoint.
Arm/Group Title Advanced Medullary Thyroid Carcinoma Group Differentiated Thyroid Carcinoma
Hide Arm/Group Description:
Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 17 24
Measure Type: Number
Unit of Measure: participants
Grade 3 or Higher 4 9
Grade 4 or Higher 3 0
Grade 5 1 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%) # Events
Total   13/41 (31.71%)    
Cardiac disorders   
Atrial fibrillation  1  1/41 (2.44%)  1
Atrial flutter  1  1/41 (2.44%)  1
Myocardial ischemia  1  1/41 (2.44%)  1
Supraventricular tachycardia  1  1/41 (2.44%)  1
Ventricular fibrillation  1  1/41 (2.44%)  1
Ear and labyrinth disorders   
Hearing impaired  1  1/41 (2.44%)  1
Tinnitus  1  1/41 (2.44%)  1
Gastrointestinal disorders   
Abdominal distension  1  1/41 (2.44%)  1
Abdominal pain  1  1/41 (2.44%)  1
Gastritis  1  1/41 (2.44%)  1
Nausea  1  2/41 (4.88%)  2
Vomiting  1  2/41 (4.88%)  2
General disorders   
Edema limbs  1  1/41 (2.44%)  1
Fever  1  1/41 (2.44%)  1
Infections and infestations   
Abdominal infection  1  1/41 (2.44%)  1
Infection  1  1/41 (2.44%)  1
Investigations   
Aspartate aminotransferase increased  1  1/41 (2.44%)  1
Blood bilirubin increased  1  1/41 (2.44%)  1
Gamma-glutamyltransferase increased  1  1/41 (2.44%)  1
Platelet count decreased  1  1/41 (2.44%)  1
Metabolism and nutrition disorders   
Serum potassium decreased  1  1/41 (2.44%)  3
Serum sodium decreased  1  1/41 (2.44%)  1
Nervous system disorders   
Headache  1  1/41 (2.44%)  1
Respiratory, thoracic and mediastinal disorders   
Atelectasis  1  1/41 (2.44%)  1
Dyspnea  1  2/41 (4.88%)  2
Hypoxia  1  1/41 (2.44%)  1
Pleural effusion  1  1/41 (2.44%)  1
Pneumonitis  1  1/41 (2.44%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Patients
Affected / at Risk (%) # Events
Total   39/41 (95.12%)    
Blood and lymphatic system disorders   
Hemoglobin decreased  1  24/41 (58.54%)  104
Lymph node pain  1  2/41 (4.88%)  3
Cardiac disorders   
Cardiac disorder  1  1/41 (2.44%)  1
Ear and labyrinth disorders   
Ear disorder  1  1/41 (2.44%)  1
Ear pain  1  1/41 (2.44%)  1
Hearing impaired  1  1/41 (2.44%)  11
Tinnitus  1  1/41 (2.44%)  12
Endocrine disorders   
Hypothyroidism  1  1/41 (2.44%)  4
Eye disorders   
Photophobia  1  1/41 (2.44%)  1
Gastrointestinal disorders   
Constipation  1  2/41 (4.88%)  13
Diarrhea  1  25/41 (60.98%)  63
Dry mouth  1  1/41 (2.44%)  1
Dyspepsia  1  3/41 (7.32%)  6
Dysphagia  1  6/41 (14.63%)  17
Ear, nose and throat examination abnormal  1  1/41 (2.44%)  1
Hemorrhoids  1  1/41 (2.44%)  1
Mucositis oral  1  2/41 (4.88%)  2
Nausea  1  22/41 (53.66%)  93
Tooth disorder  1  1/41 (2.44%)  1
Vomiting  1  11/41 (26.83%)  23
General disorders   
Chest pain  1  1/41 (2.44%)  1
Chills  1  4/41 (9.76%)  6
Edema limbs  1  4/41 (9.76%)  15
Fatigue  1  26/41 (63.41%)  72
Fever  1  3/41 (7.32%)  4
Localized edema  1  1/41 (2.44%)  1
Pain  1  3/41 (7.32%)  4
Hepatobiliary disorders   
Cholecystitis  1  1/41 (2.44%)  1
Infections and infestations   
Catheter related infection  1  1/41 (2.44%)  1
Infection  1  2/41 (4.88%)  2
Upper respiratory infection  1  1/41 (2.44%)  1
Urinary tract infection  1  1/41 (2.44%)  5
Injury, poisoning and procedural complications   
Bruising  1  2/41 (4.88%)  6
Investigations   
Alanine aminotransferase increased  1  21/41 (51.22%)  74
Alkaline phosphatase increased  1  19/41 (46.34%)  71
Aspartate aminotransferase increased  1  18/41 (43.90%)  64
Blood bilirubin increased  1  9/41 (21.95%)  41
Creatinine increased  1  1/41 (2.44%)  1
Gamma-glutamyltransferase increased  1  6/41 (14.63%)  17
Leukocyte count decreased  1  9/41 (21.95%)  42
Lymphocyte count decreased  1  10/41 (24.39%)  26
Neutrophil count decreased  1  5/41 (12.20%)  11
Platelet count decreased  1  3/41 (7.32%)  5
Weight loss  1  4/41 (9.76%)  5
Metabolism and nutrition disorders   
Anorexia  1  7/41 (17.07%)  12
Blood bicarbonate decreased  1  1/41 (2.44%)  1
Blood glucose increased  1  6/41 (14.63%)  9
Dehydration  1  2/41 (4.88%)  2
Serum albumin decreased  1  2/41 (4.88%)  2
Serum calcium decreased  1  4/41 (9.76%)  6
Serum calcium increased  1  4/41 (9.76%)  4
Serum glucose decreased  1  2/41 (4.88%)  3
Serum potassium decreased  1  5/41 (12.20%)  7
Serum potassium increased  1  1/41 (2.44%)  1
Serum sodium decreased  1  2/41 (4.88%)  3
Serum sodium increased  1  2/41 (4.88%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia  1  4/41 (9.76%)  7
Arthritis  1  5/41 (12.20%)  12
Back pain  1  5/41 (12.20%)  9
Bone pain  1  5/41 (12.20%)  9
Muscle weakness lower limb  1  1/41 (2.44%)  1
Musculoskeletal disorder  1  1/41 (2.44%)  1
Myalgia  1  8/41 (19.51%)  17
Neck pain  1  5/41 (12.20%)  12
Pain in extremity  1  1/41 (2.44%)  1
Nervous system disorders   
Dizziness  1  4/41 (9.76%)  22
Dysgeusia  1  5/41 (12.20%)  8
Headache  1  6/41 (14.63%)  11
Peripheral motor neuropathy  1  1/41 (2.44%)  2
Peripheral sensory neuropathy  1  5/41 (12.20%)  15
Psychiatric disorders   
Anxiety  1  6/41 (14.63%)  18
Depression  1  6/41 (14.63%)  17
Insomnia  1  6/41 (14.63%)  19
Renal and urinary disorders   
Urinary frequency  1  1/41 (2.44%)  1
Reproductive system and breast disorders   
Irregular menstruation  1  1/41 (2.44%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  2/41 (4.88%)  5
Cough  1  12/41 (29.27%)  30
Dyspnea  1  15/41 (36.59%)  41
Epistaxis  1  1/41 (2.44%)  1
Hiccups  1  1/41 (2.44%)  1
Voice alteration  1  5/41 (12.20%)  7
Skin and subcutaneous tissue disorders   
Alopecia  1  5/41 (12.20%)  6
Body odor  1  7/41 (17.07%)  15
Dry skin  1  1/41 (2.44%)  2
Pruritus  1  2/41 (4.88%)  2
Rash acneiform  1  1/41 (2.44%)  1
Rash desquamating  1  1/41 (2.44%)  1
Skin disorder  1  2/41 (4.88%)  3
Sweating  1  4/41 (9.76%)  10
Vascular disorders   
Flushing  1  2/41 (4.88%)  3
Hot flashes  1  1/41 (2.44%)  3
Hypertension  1  1/41 (2.44%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Results Point of Contact
Name/Title: Jeffrey F. Moley, M.D.
Organization: Washington University School of Medicine
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00118248     History of Changes
Obsolete Identifiers: NCT01646944, NCT01664351
Other Study ID Numbers: NCI-2009-00063
NCI-2009-00063 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
JHOC-B/06/174
NCI-6482
JHOC-JS0652
CDR0000433150
MC0476 ( Other Identifier: Mayo Clinic )
6482 ( Other Identifier: CTEP )
N01CM62205 ( U.S. NIH Grant/Contract )
P30CA015083 ( U.S. NIH Grant/Contract )
N01CM62207 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2005
First Posted: July 11, 2005
Results First Submitted: September 20, 2013
Results First Posted: May 6, 2014
Last Update Posted: February 15, 2017