Clinical Trial: Sorafenib Plus Paclitaxel in Adreno-Cortical-Cancer Patients

Study Status: Withdrawn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

Official Title: Sorafenib Plus Paclitaxel Metronomic Chemotherapy in Adreno-Cortical-Carcinoma Patients Progressing After 1st or 2nd Line Cytotoxic Chemotherapy

Brief Summary: The study is designed as a Phase II, prospective, non randomized, open-label, single arm, multicenter trial, in which patients with locally advanced or metastatic ACC not amenable to complete surgical resection and progressing to cytotoxic chemotherapy will receive Sorafenib plus metronomic chemotherapy as treatment.The aim of this phase II trial is to evaluate the clinical benefit and toxicity of the combination of Sorafenib plus metronomic chemotherapy in patients with locally advanced or metastatic ACC who progressed after first or second line chemotherapy.

Detailed Summary:

The study is designed as a Phase II, prospective, non randomized, open-label, single arm, multicenter trial, in which patients with locally advanced or metastatic ACC not amenable to complete surgical resection.

STUDY OBJECTIVES

The aim of this phase II trial is to evaluate the clinical benefit and toxicity of the combination of Sorafenib plus metronomic chemotherapy in patients with locally advanced or metastatic ACC who progressed after first or second line chemotherapy.

Primary objective

To assess the clinical benefit as measured by a non progressing rate after 4 months of the combination of Sorafenib plus weekly Paclitaxel in patients with locally advanced or metastatic ACC who progressed after first or second line chemotherapy.

Secondary objectives

  • Assessment of Objective (Complete and Partial) Response Rates
  • Assessment of Duration of Response
  • Assessment of Hormonal Response
  • Assessment of Progression-Free Survival
  • Assessment of Overall Survival
  • Assessment of the relationship between specific "biomarkers" and cancer- and treatment-related outcomes
  • Assessment of Quality of Life by EORTC QLQ-C30
  • Assessment of Toxicity

ENDPOINTS

The first disease assessment will be performed after 8-weeks, subsequent assessments will be performed every 12
Sponsor: University of Turin, Italy

Current Primary Outcome: Disease free survival [ Time Frame: 4 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Overall survival [ Time Frame: 4 months ]

Original Secondary Outcome: Same as current

Information By: University of Turin, Italy

Dates:
Date Received: November 5, 2008
Date Started: April 2008
Date Completion: October 2010
Last Updated: February 23, 2009
Last Verified: February 2009