Sunitinib in Refractory Adrenocortical Carcinoma (SIRAC)
Although a first randomized trial in patients with advanced ACC leading to the establishment of a first line cytotoxic chemotherapy is ongoing (FIRM-ACT), the failure rate even of this FIRM-ACT study is most likely clearly above 50%. Therefore, the majority of participating patients urgently need a new treatment option. However, up to date there is no evidence for a single regimen that might be promising in these treatment-refractory patients with ACC.
Sunitinib is an oral multitargeted tyrosine kinase inhibitor with anti-tumor and antiangiogenic activities, which is successfully tested in the treatment of patients with metastatic renal cell carcinoma, gastrointestinal stromal and neuroendocrine tumors after failure of standard cytotoxic chemotherapy.
The primary objective of this trial is to estimate the response (defined as progression-free survival of ≥ 12 weeks) rate associated with Sunitinib treatment in patients advanced ACC progressing after cytotoxic chemotherapy.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sunitinib in Refractory Adrenocortical-Carcinoma Patients Progressing After Cytotoxic Chemotherapy|
- Assessment of clinical benefit as measured by non progressing rate after 12 weeks of treatment with Sunitinib
- Assessment of Objective Response Rates (ORR) and duration of response (DR)
- Assessment of progression-free survival
- Assessment of overall survival
- Assessment of the relationship between specific "biomarker" and cancer- and treatment-related outcomes
- Assessment of quality of life by EORTC QLQ-C30
- Assessment of toxicity
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||June 2011|
|Estimated Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453895
|Dept. of Medicine I, University of Wuerzburg|
|Wuerzburg, Germany, 97080|
|Principal Investigator:||Martin Fassnacht, MD||University of Wuerzburg|