NCT00786110

Sorafenib Plus Paclitaxel in Adreno-Cortical-Cancer Patients

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 description

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 weeks until end of the study. Primary endpoint * Progression-Free Survival rate ≥ 40% after 4 months Secondary endpoints * Response rate evaluation will be performed according to the RECIST criteria. The same methods of measurement and the same technique should be used to characterize each identified and reported lesion at baseline and during study. TREATMENT SCHEME Treatment scheme consisted of oral Sorafenib 400 mg p.o. bid plus intravenous Paclitaxel 60 mg/mq/weekly i.v., until disease progression.

Conditions

• Adrenocortical Carcinoma

Interventions

Type	Name	Description
DRUG	Sorafenib	Treatment scheme consisted of oral Sorafenib 400 mg p.o. bid until disease progression.
DRUG	Paclitaxel	Intravenous Paclitaxel 60 mg/mq/weekly i.v., until disease progression.

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-10-01
• Completion: 2010-10-01
• First posted: 2008-11-06
• Last updated: 2009-02-24

Locations

5 sites across 1 country: Italy