Sorafenib in Relapsed High Grade Osteosarcoma

NCT ID: NCT00889057

Last Updated: 2013-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-06-30

Brief Summary

Aim of this exploratory phase II study is to assess the clinical activity of sorafenib as single agent, in terms of percentage of patients with high grade advanced osteosarcoma free from progression following 4 months of therapy

Conditions

Osteosarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sorafenib

Group Type: EXPERIMENTAL

sorafenib

Intervention Type: DRUG

400 mg bid until progression or inacceptable toxicity

Interventions

sorafenib

400 mg bid until progression or inacceptable toxicity

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• histologically documented and not surgically resectable or metastatic high-grade osteosarcoma which progressed after first or second line treatments for relapsing disease.
• measurable disease as defined by having at least one lesion that can be accurately measured by means of CT or MRI.
• ECOG PS of 0, 1 and an estimated life expectancy of at least 3 months. ECOG P.S. 2 is acceptable provided that it depends solely on orthopedic problems
• Age ≥15 years.
• Adequate bone marrow, liver and renal function
• Written informed consent

Exclusion Criteria

• Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
• Coexisting malignancies, except for basal or epithelial cell carcinoma of the skin or other solid tumors curatively treated with no evidence of disease for ≥3 years.
• History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
• History of HIV infection or chronic hepatitis B or C.
• Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
• Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
• Patients with seizure disorders requiring medication (such as steroids or anti-epileptics)
• Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
• Patients with evidence or history of bleeding diathesis
• Patients undergoing renal dialysis
• Patients unable to swallow oral medications

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Italian Sarcoma Group

NETWORK

Sponsor Role: lead

Responsible Party

Prof. Massimo Aglietta

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Massimo Aglietta, MD

Role: STUDY_CHAIR

I.R.C.C - FPO Candiolo

Giovanni Grignani, MD

Role: PRINCIPAL_INVESTIGATOR

I.R.C.C. - FPO Candiolo

Locations

Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors

Bologna, Bologna, Italy

Istituto Nazionale Tumori - Unit of Medical Oncology

Milan, Milano, Italy

I.R.C.C. - Unit of Medical Oncology

Candiolo, Torino, Italy

Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology

Torino, Torino, Italy

Countries

Italy

Other Identifiers

EudraCT Number: 2007-004396-19

Identifier Type: -

Identifier Source: secondary_id

HGosteo-BAY

Identifier Type: -

Identifier Source: org_study_id