Status:
COMPLETED
Sorafenib in Relapsed High Grade Osteosarcoma
Lead Sponsor:
Italian Sarcoma Group
Conditions:
Osteosarcoma
Eligibility:
All Genders
15-75 years
Phase:
PHASE2
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00889057
Start Date
January 1 2008
End Date
June 1 2011
Last Update
March 28 2013
Active Locations (4)
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1
Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna, Bologna, Italy, 40136
2
Istituto Nazionale Tumori - Unit of Medical Oncology
Milan, Milano, Italy, 20133
3
I.R.C.C. - Unit of Medical Oncology
Candiolo, Torino, Italy, 10060
4
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
Torino, Torino, Italy, 10126