Tanespimycin in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer
Recurrent Thyroid Cancer
Stage IV Follicular Thyroid Cancer
Stage IV Papillary Thyroid Cancer
Thyroid Gland Medullary Carcinoma
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of 17-Allylaminogeldanamycin (17AAG) in Advanced Medullary and Differentiated Thyroid Carcinoma|
- Proportion of Patients Who Have Remained on Treatment and Progression-free at Least One Year After Start of 17-AAG (Tanespimycin) [ Time Frame: 1 year ]
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.
- Overall Response [ Time Frame: Baseline, every 3 courses, and at the end of treatment study ]
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.
- Progression-Free Survival [ Time Frame: Every 3 months for up to 3 years ]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.
- Overall Survival [ Time Frame: Every 3 months until progression, and then every 6 months up to 3 years ]Defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the Kaplan-Meier method.
- Toxicity [ Time Frame: Every 3 courses during treatment (median cycle number was 5 with a maximum of 38 cycles) ]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.
|Study Start Date:||December 2004|
|Study Completion Date:||April 2012|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Experimental: Treatment (chemotherapy)
Patients receive 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.
Other Name: 17-AAG
I. Determine the 1-year treatment failure rate in patients with inoperable locoregionally advanced or metastatic medullary or differentiated thyroid carcinoma treated with 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) (tanespimycin).
I. Determine the toxicity of this drug in these patients. Determine the 1-year progression-free rate in patients treated with this drug.
II. Determine the response rate and duration of response in patients treated with this drug.
III. Determine the time to treatment failure and time to subsequent therapy in patients treated with this drug.
IV. Determine the time to disease progression and overall survival of patients treated with this drug.
V. Correlate the incidence rate of RAS, RAF, and RET mutations with clinical outcome in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to type of thyroid carcinoma (medullary vs differentiated).
Patients receive tanespimycin intravenously (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.
After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from study entry.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118248
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Jeffrey Moley||Mayo Clinic|