Phase II Trial for the Treatment of Relapsed Osteosarcoma

Multicentric, Randomized Phase II Trial for the Treatment of Patients With Relapsed Osteosarcoma

Phase II randomized study for the comparison of the Gemcitabine plus Docetaxel and the Ifosfamide treatment of patients with relapsed osteosarcoma

Patients with relapsed osteosarcoma will be randomized to receive Gemcitabine plus Docetaxel or High Doses Ifosfamide (continuous infusion) every 3 weeks, up to 6 weeks

Inclusion Criteria:

• Diagnosis of high grade osteosarcoma recurrence
• Resectable or unresectable recurrence disease within 24 months from the initial diagnosis
• Pleuro-pulmonary recurrence with more than 2 nodules within 24 months from the initial diagnosis
• Unresectable first relapse within 24 months from the initial diagnosis
• Resectable or unresectable second of further recurrence of high grade osteosarcoma
• Age at diagnosis at least 4years.
• Karnofsky performance status over 60%.
• Renal function and hepatic In normal limits for age.
• L eft ejection ventricular fraction over 50%.
• White blood cells over 3000 million/liter and platelets 100000 million/liter
• Birth potential female must agreed to contraception
• Signed written informed consent

Exclusion Criteria:

• Contraindication to the use of any study drugs
• Mental, social and geographic conditions which fail to ensure adequate adherence to the study
• Hepatitis and human immunodeficiency virus active infection
• Pregnancy or breast-feeding
• Previous treatment with Gemcitabine, Docetaxel and Ifosfamide