Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma (GEIS-29)

Broto, Javier Martín, M.D.

Status and phase

Completed

Phase 2

Conditions

Osteosarcoma

Treatments

Drug: Gemcitabine plus rapamycin

Study type

Interventional

Identifiers

NCT02429973

EC11-444 OSTEOSARC

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

All

Ages

Under 80 years old

Volunteers

No Healthy Volunteers

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