Osteosarcoma
Conditions
Keywords
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 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.
Interventions
DRUGGemcitabine plus rapamycin
Gemcitabine and rapamycin given in combination
Sponsors
Broto, Javier Martín, M.D.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) rate | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response according to RECIST | 6 months |
Outcome results
None listed