Sorafenib in Relapsed High Grade Osteosarcoma

Sponsor

Italian Sarcoma Group (Other)

Overall Status

Completed

CT.gov ID

NCT00889057

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

8.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Osteosarcoma	Drug: sorafenib	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II, Open Label, Non-randomized Study of Second or Third Line Treatment With Sorafenib (BAY 43-9006) in Patients Affected by Relapsed High-grade Osteosarcoma.

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sorafenib	Drug: sorafenib 400 mg bid until progression or inacceptable toxicity

Arm

Intervention/Treatment

Experimental: sorafenib

Drug: sorafenib

400 mg bid until progression or inacceptable toxicity

Outcome Measures

Primary Outcome Measures

Tumor assessment through radiologic evaluation. [every 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	I.R.C.C. - Unit of Medical Oncology	Candiolo	Torino	Italy	10060
2	Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors	Bologna		Italy	40136
3	Istituto Nazionale Tumori - Unit of Medical Oncology	Milano		Italy	20133
4	Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology	Torino		Italy	10126