Sorafenib in Relapsed High Grade Osteosarcoma

NCT00889057 | Completed Phase 2

• 2 other identifiers: HGosteo-BAYEudraCT Number: 2007-004396-19
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

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

Keywords

osteosarcoma; sorafenib; target therapy

Outcome Measures

Primary Outcomes (1)

• Tumor assessment through radiologic evaluation.

  every 8 weeks

Study Arms (1)

sorafenib

EXPERIMENTAL

Drug: sorafenib

Interventions

sorafenib DRUG

400 mg bid until progression or inacceptable toxicity

sorafenib

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Italian Sarcoma Group: lead

Study Sites (4)

Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors

Bologna, Bologna, 40136, Italy

Location

Istituto Nazionale Tumori - Unit of Medical Oncology

Milan, Milano, 20133, Italy

Location

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

Candiolo, Torino, 10060, Italy

Location

Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology

Torino, Torino, 10126, Italy

Location

MeSH Terms

Conditions

Osteosarcoma

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Massimo Aglietta, MD

  I.R.C.C - FPO Candiolo

  STUDY CHAIR

• Giovanni Grignani, MD

  I.R.C.C. - FPO Candiolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 28, 2009
• Study Start: January 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: March 28, 2013

Record last verified: 2013-03

Locations

IT (4)