NCT02429973

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Broto, Javier Martín, M.D. · Individual
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Osteosarcoma

Interventions

Type	Name	Description
DRUG	Gemcitabine plus rapamycin	Gemcitabine and rapamycin given in combination

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-12-01
• Completion: 2015-04-01
• First posted: 2015-04-29
• Last updated: 2015-04-29