patients affected by relapsed high-grade osteosarcoma MedDRA version: 9.1 Level: LLT Classification code 10031296 Term: Osteosarcoma recurrent
Conditions
Interventions
Trade Name: NEXAVAR*112CPR RIV 200MG
Pharmaceutical Form: Tablet
INN or Proposed INN: SORAFENIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Sponsors
ITALIAN SARCOMA GROUP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with histologically documented and not surgically resectable or metastatic high-grade osteosarcoma which progressed after first or second line treatments for relapsing disease. 2) Measurable disease as defined by having at least one lesion that can be accurately measured by means of CT or MRI. Baseline evaluations must be completed within 2 weeks prior to enrollment. 3) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 and an estimated life expectancy of at least 3 months. Patients with and ECOG P.S. 2 are eligible if the P.S.2 depends solely on orthopedic problems. 4)Age >/= 15 years. 5)Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of treatment: -Hemoglobin > 9.0 g/dl; -Absolute neutrophil count (ANC)>1,500/mm3. -Platelet count >/=100,000/μl. -Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1)Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. 2)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. 3)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. 4)History of HIV infection or chronic hepatitis B or C. 5)Active clinically serious infections (> grade 2 NCI-CTC version 3.0) 6)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) 7)Patients with seizure disorders requiring medication (such as steroids or anti-epileptics) 8)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. 9)Patients with evidence or history of bleeding diathesis. 10)Patients undergoing renal dialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the antitumor activity of sorafenib 400 mg twice a day as second or third line treatment of relapsed high-grade osteosarcoma (not resectable, not resectable in a radical fashion, metastatic);Secondary Objective: To explore sorafenib activity in this unfavourable OS subset. This will be accomplished by both recording overall survival, response rate (dimensional reduction), oncogene expression and activation. Any improvement in patients quality of life will be captured by the Pain and Analgesic scale. Finally, a specific effort will be conducted to evaluate the pattern of response, if any, given the peculiar patterns of response observed in solid tumors with molecular-targeted therapy.;Primary end point(s): Percentage of patients progression free at 4 months | — |
Countries
Italy
Outcome results
None listed