Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma

Multicenter and Prospective Phase II Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma

Multicenter and prospective phase II trial with gemcitabine and rapamycin in second line of metastatic osteosarcoma. The study includes 6 cycles of the combination gemcitabine+rapamycin in metastatic or unresectable osteosarcoma patients.

The trial seeks to analyze progression free survival (PFS), measured as PFS rate at 4 months, in patients with metastatic osteosarcoma who have previously received the most active drugs in this disease (methotrexate, cisplatin, adriamycin and ifosfamide). The treatment schedule consists of a maximum of 6 cycles of 3 weeks of gemcitabine+rapamycin. Gemcitabine is given at 800 mg/m2 in days 1 and 8 in cycles of 21 days. Rapamycin is given at 5 mg per day during treatment duration.

Inclusion Criteria:

• Informed consent signed before any trial test
• Age equal or less than 80 years
• Histological diagnosis of high-grade, metastatic or unresectable osteosarcoma in progression
• Previous treatment with drugs used in first line: methotrexate, adriamycin, platinum
• Measurable disease, acoording to RECIST criteria
• ECOG 0-2

Exclusion Criteria:

• Patients who have been irradiated on target lesions
• ECOG >2
• Bilirubin levels over normal values. Creatinine over 1.6 mg/dL
• History of other cancers except basal cell cancer or cervical cancer adequately treated
• Serious cardiovascular disease