Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer
This phase II trial is studying the side effects and how well pazopanib hydrochloride works in treating patients with advanced thyroid cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by stopping blood flow to the tumor.
Anaplastic Thyroid Cancer
Recurrent Thyroid Cancer
Stage III Follicular Thyroid Cancer
Stage III Papillary Thyroid Cancer
Stage IV Follicular Thyroid Cancer
Stage IVA Follicular Thyroid Cancer
Stage IVA Papillary Thyroid Cancer
Stage IVB Follicular Thyroid Cancer
Stage IVB Papillary Thyroid Cancer
Stage IVC Follicular Thyroid Cancer
Stage IVC Papillary Thyroid Cancer
Thyroid Gland Medullary Carcinoma
Drug: pazopanib hydrochloride
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of GW 786034 (Pazopanib) in Advanced Thyroid Cancer|
- Proportion of patients who have achieved an objective response to the study agent [ Time Frame: Every 8 weeks and then every 4 weeks, assessed up to 3 years ] [ Designated as safety issue: No ]Objective response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Confirmed tumor response (DTC expanded cohort) [ Time Frame: 2 consecutive evaluations at least 8 weeks apart and then every 4 weeks, assessed up to 3 years ] [ Designated as safety issue: No ]Tumor response (complete or partial response) as assessed by RECIST criteria noted as objective status on 2 consecutive evaluations at least 8 weeks apart for patients with DTC who are thyroglobulin antibody negative
- Proportion of patients with differentiated thyroid cancer (DTC) and medullary thyroid cancer (MTC) who have not failed treatment at 6 months (3 months for anaplastic thyroid cancer [ATC]) [ Time Frame: At 3 (ATC) and 6 months (DTC and MTC) ] [ Designated as safety issue: No ]The proportion of patients who have not failed treatment due to disease progression, adverse reactions, refusal for further participation, or who went on to alternate therapy at 6 months (3 months for ATC patients) will be calculated and summarized independently within each of the patient groups. Assuming that the incidence of response is binomially distributed, 90% binomial confidence intervals will also be calculated.
- Proportion of patients in which the radioactive iodine scan have changed from "no uptake" to "any uptake" [ Time Frame: At 6 months (at 3 months for patients with ATC) ] [ Designated as safety issue: No ]
- Proportion of patients achieving a biochemical response in appropriate tumor markers [ Time Frame: At baseline, weeks 1-4 of course 1, retreatment weeks 4, 8, 12, 16, and then at the end of treatment. ] [ Designated as safety issue: No ]Levels of free VEGF and PDGF will be explored in a graphical manner in pre-treatment and multiple on-treatment samples.
- Clinical and biologic responses as well as tolerability simultaneously and independently in each patient cohort (differentiated, medullary, and anaplastic thyroid cancer cohorts) [ Time Frame: not ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: Weekly during treatment and at the end of study treatment ] [ Designated as safety issue: No ]Toxicity will be assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
- Times to progression and death [ Time Frame: Time from registration to the date of progression or last follow-up, whichever comes first, assessed up to 3 years ] [ Designated as safety issue: No ]Time to progression will be estimated using the method of Kaplan-Meier. In addition, the 6-month progression-free rate will be evaluated using the 6-month rates and associated confidence intervals. Competing risk analyses may be done to evaluate time to progression, allowing for going on to alternate treatment or death prior to progression as competing risks.
- Time to treatment failure and time to subsequent therapy [ Time Frame: Time from registration to the date the patient discontinues treatment ] [ Designated as safety issue: No ]Distribution will be estimated using the method of Kaplan-Meier. In addition, the time to subsequent therapy will also be evaluated using a similar approach.
- Duration of response [ Time Frame: From the date of documentation of response (PR or CR) until the date of progression or last follow-up (whichever comes first) in the subset of patients with confirmed response ] [ Designated as safety issue: No ]
- Biomarker-based response [ Time Frame: At baseline and after treatment ] [ Designated as safety issue: No ]Rates will be summarized assuming they are binomially distributed, and the biomarker levels themselves will be explored both quantitatively and graphically before and after treatment
|Study Start Date:||February 2008|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (tyrosine kinase inhibitor therapy)
Patients receive pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: pazopanib hydrochloride
Other Names:Other: laboratory biomarker analysis
I. To establish the safety and efficacy of pazopanib hydrochloride in patients with differentiated, medullary, or anaplastic thyroid cancer.
I. To assess the impact of pazopanib hydrochloride on serum and plasma VEGF levels.
II. To explore the potential relationship between changes in thyroglobulin levels and tumor response in patients with advanced differentiated thyroid cancer known to be thyroglobulin antibody negative.
Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 6 months or until 3 years after registration.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00625846
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, Colorado|
|University of Colorado Cancer Center - Anschutz Cancer Pavilion|
|Aurora, Colorado, United States, 80045|
|University of Colorado|
|Denver, Colorado, United States, 80217-3364|
|United States, District of Columbia|
|Howard University Hospital|
|Washington, District of Columbia, United States, 20060|
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224-9980|
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|United States, Maryland|
|Johns Hopkins University/Sidney Kimmel Cancer Center|
|Baltimore, Maryland, United States, 21287|
|United States, Michigan|
|Wayne State University/Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Saint Louis Park, Minnesota, United States, 55416|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|CoxHealth South Hospital|
|Springfield, Missouri, United States, 65807|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53792|
|China, Hong Kong|
|Chinese University of Hong Kong-Prince of Wales Hospital|
|Shatin, Hong Kong, China, OX1 3UJ|
|National University Hospital|
|Singapore, Singapore, 119074|
|National Cancer Centre|
|Singapore, Singapore, 169610|
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Principal Investigator:||Keith Bible||Mayo Clinic|