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Sorafenib in Relapsed High Grade Osteosarcoma

Primary Purpose

Osteosarcoma

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

sorafenib

About this trial

This is an interventional treatment trial for Osteosarcoma focused on measuring osteosarcoma, sorafenib, target therapy

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

I.R.C.C. - Unit of Medical Oncology
Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Istituto Nazionale Tumori - Unit of Medical Oncology
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sorafenib

Arm Description

Outcomes

Primary Outcome Measures

Tumor assessment through radiologic evaluation.

Secondary Outcome Measures

Full Information

NCT ID

NCT00889057

First Posted

April 27, 2009

Last Updated

March 26, 2013

Sponsor

Italian Sarcoma Group

1. Study Identification

Unique Protocol Identification Number

NCT00889057

Brief Title

Sorafenib in Relapsed High Grade Osteosarcoma

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 Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Italian Sarcoma Group

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteosarcoma

Keywords

osteosarcoma, sorafenib, target therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sorafenib

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

sorafenib

Intervention Description

400 mg bid until progression or inacceptable toxicity

Primary Outcome Measure Information:

Title

Tumor assessment through radiologic evaluation.

Time Frame

every 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Massimo Aglietta, MD

Organizational Affiliation

I.R.C.C - FPO Candiolo

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Giovanni Grignani, MD

Organizational Affiliation

I.R.C.C. - FPO Candiolo

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Candiolo

State/Province

Torino

ZIP/Postal Code

10060

Country

Italy

Facility Name

Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors

City

Bologna

ZIP/Postal Code

40136

Country

Italy

Facility Name

Istituto Nazionale Tumori - Unit of Medical Oncology

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology

City

Torino

ZIP/Postal Code

10126

Country

Italy

12. IPD Sharing Statement

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Sorafenib in Relapsed High Grade Osteosarcoma

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