Sorafenib Plus Paclitaxel in Adreno-Cortical-Cancer Patients (PAXO)
Recruitment status was: Recruiting
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sorafenib Plus Paclitaxel Metronomic Chemotherapy in Adreno-Cortical-Carcinoma Patients Progressing After 1st or 2nd Line Cytotoxic Chemotherapy|
- Disease free survival [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 4 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||October 2010|
|Estimated Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Experimental: 1 arm only
One arm only with Sorafenib plus Paclitaxel Patients enrolled will undergo strict follow-up
Intervention: Sorafenib plus Paclitaxel
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.
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.
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.
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.
- 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
The first disease assessment will be performed after 8-weeks, subsequent assessments will be performed every 12 weeks until end of the study.
- Progression-Free Survival rate ≥ 40% after 4 months
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786110
|Department of Clinical and Biological Sciences, University of Turin|
|Azienda Ospedaliera di Padova|
|Azienda Ospedaliera Università di Palermo|
|Policlinico Universitario Campus Biomedico- Roma|
|Study Chair:||Alfredo Berruti MD||Internal Medicine, Department of Clinical and Biological Sciences, University of Turin, Italy|
|Study Director:||Eric Baudin||Oncologie Endocrinienne et Médecine Nucléaire, Institut Gustave Roussy, Villejuif, France.|
|Principal Investigator:||Massimo Terzolo, MD||Internal Medicine, Department of Clinical and Biological Sciences, University of Turin, Italy|
|Study Director:||Sophie Leboulleux||Service de Médecine Nucléaire et de Cancérologie Endocrinienne, Institut Gustave-|