MedTrace Logo

Sorafenib Plus Paclitaxel in Adreno-Cortical-Cancer Patients

NCT00786110 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-02-24

No results posted yet for this study

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.

Conditions

  • Adrenocortical Carcinoma

Interventions

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.

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Alfredo Berruti MD · Internal Medicine, Department of Clinical and Biological Sciences, University of Turin, Italy

  • Eric Baudin · Oncologie Endocrinienne et Médecine Nucléaire, Institut Gustave Roussy, Villejuif, France.

  • Massimo Terzolo, MD · Internal Medicine, Department of Clinical and Biological Sciences, University of Turin, Italy

  • Sophie Leboulleux · Service de Médecine Nucléaire et de Cancérologie Endocrinienne, Institut Gustave-

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-10-31
Completion
2010-10-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00786110 on ClinicalTrials.gov