Clinical Trial: Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: Broto, Javier Martín, M.D.

Current Primary Outcome: Progression free survival (PFS) rate [ Time Frame: 4 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Tumor response according to RECIST [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: Broto, Javier Martín, M.D.

Dates:
Date Received: April 24, 2015
Date Started: July 2012
Date Completion:
Last Updated: April 28, 2015
Last Verified: April 2015