Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Broto, Javier Martín, M.D.
• Treatments: Everolimus; Gemcitabine; Sirolimus

Criteria

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