Clinical Trial: Sunitinib in Refractory Adrenocortical Carcinoma

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Sunitinib in Refractory Adrenocortical-Carcinoma Patients Progressing After Cytotoxic Chemotherapy

Brief Summary:

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.


Detailed Summary:
Sponsor: University of Wuerzburg

Current Primary Outcome: Assessment of clinical benefit as measured by non progressing rate after 12 weeks of treatment with Sunitinib

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • 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


Information By: University of Wuerzburg

Dates:
Date Received: March 28, 2007
Date Started: July 2007
Date Completion: June 2011
Last Updated: July 6, 2010
Last Verified: July 2010