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.
Recurrent Thyroid Gland Carcinoma
Stage III Thyroid Gland Follicular Carcinoma
Stage III Thyroid Gland Papillary Carcinoma
Stage IV Thyroid Gland Follicular Carcinoma
Stage IVA Thyroid Gland Follicular Carcinoma
Stage IVA Thyroid Gland Papillary Carcinoma
Stage IVB Thyroid Gland Follicular Carcinoma
Stage IVB Thyroid Gland Papillary Carcinoma
Stage IVC Thyroid Gland Follicular Carcinoma
Stage IVC Thyroid Gland Papillary Carcinoma
Thyroid Gland Medullary Carcinoma
Thyroid Gland Undifferentiated (Anaplastic) Carcinoma
Other: Laboratory Biomarker Analysis
Drug: Pazopanib Hydrochloride
|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|
- 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 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
- 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
- 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 ]
- 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 ]
- 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.
- 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 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.
- 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.
- 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.
- 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.
|Study Start Date:||February 2008|
|Estimated Primary Completion Date:||March 2016 (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.
Other: Laboratory Biomarker Analysis
Correlative studiesDrug: Pazopanib Hydrochloride
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
Show 25 Study Locations
|Principal Investigator:||Keith Bible||Mayo Clinic|