Treatment for Patients With Metastatic Thyroid Cancer
This study is being done to find out the good and bad effects of an investigational drug that is not approved for sale, called AG-013736. Tumors need blood vessels in order to continue to grow, and AG-013736 is thought to work by playing a role in preventing new blood vessels from growing. We want to see if AG-013736 has any effect on your disease by making your tumor smaller and if so, for how long. We also want to test the safety [the effect on your body] of AG-013736 and to measure the amount of AG-013736 that gets into your blood. AG-013736 has been given to over 140 patients with cancer on other studies.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer Who Are Refractory to or Not Suitable Candidates for 131I Treatment|
- The primary objective of this study is to determine the response rate of AG-013736 in patients with metastatic thyroid cancer (who are refractory to or not suitable candidates for 131I treatment). [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
- To determine the safety profile of AG-013736 [ Time Frame: Approximately 2 years ] [ Designated as safety issue: Yes ]
- To determine the progression-free survival [ Time Frame: This is a variable in the outcome measure (time frame cannot be determined). ] [ Designated as safety issue: No ]
- To determine the duration of response. [ Time Frame: The time frame cannot be determined as it is the variable that is being studied for this Outcome Measure. ] [ Designated as safety issue: No ]
- To determine overall survival. [ Time Frame: Time Frame cannot be approximated as this is the variable that is being studied in this Outcome Measure. ] [ Designated as safety issue: No ]
- To obtain blood samples for population pharmacokinetic analyses in order to explore relationships between clinical response and plasma soluble proteins. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Study Completion Date:||June 2009|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
The American Cancer Society estimates that there will be about 23,600 new cases of thyroid cancer (5,960 in men and 17,640 in women) annually in the United States, and about 1,460 people (620 men and 840 women) will die from this disease.1 It is the most common malignancy of the endocrine system. Depending upon type and stage, thyroid cancer may be treated with surgery, radioactive iodine (131I), hormone treatment, external radiation, or chemotherapy.
The systemic therapy of metastatic disease remains palliative until new agents are found that might afford a better prognosis. Thyroid tumors are often vascular, and a decrease in the number of blood vessels that supply the tumor may starve it of needed nutrients. An approach to blocking the growth of blood vessels that supply the tumor is to inhibit the VEGF receptor tyrosine kinase (VEGFR TK) signaling pathway. The VEGFR TK inhibitor SU011248 has produced 4 objective responses in 15 patients receiving the drug on Phase 1 studies.2 AG-013736 is another VEGFR TK inhibitor. Besides having potential anti-angiogenesis properties through VEGFR TK inhibition, it also has additional potential antitumor through platelet derived growth factor receptor (PDGFR) TK inhibition.
|United States, Michigan|
|University of Michigan Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Francis Worden, M.D.||University of Michigan Cancer Center|