Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma
- Registration Number
- NCT02429973
- Lead Sponsor
- Broto, Javier Martín, M.D.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Gemcitabine plus rapamycin 6 cycles of gemcitabine plus rapamycin
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) rate 4 months
- Secondary Outcome Measures
Name Time Method Tumor response according to RECIST 6 months