Patients diagnosed with metastatic osteosarcoma cancer types that have been treated with chemotherapy and have active disease that permits to receive this treatment combination.
Conditions
Interventions
Trade Name: GEMCITABINE
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: GEMCITABINE HYDROCHLORIDE
CAS Number: 122111-03-9
Concentration unit: mg milligram(s
Sponsors
JAVIER MARTÍN BROTO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient must willingly sign the informed consent before any trial tests that may not be part of the usual patient care, knowing the patient that he/she can leave the trial when desired, without this affecting the future attention. 2. Age equal or superior to 16 years. 3. Histological diagnosis of high-grade osteosarcoma, metastatic or not operable in progression. 4. Previous treatment with drugs used in first line: Methotrexate, adriamycin, platin. It is not required having received ifosfamide for inclusion. They may have received mifamurtide in first line. Might have received bifosfonates though they will have to be interrupted 1 month before inclusion. 5. Measurable disease, according to RECIST criteria. 6. Functional state 0-2 (ECOG). 7. Baseline medullary function (hemoglobin > 10 g/dL, leukocytes ? 3.000/mm3, RAN? 1,5 x 109 /l, granulocytes ? 1.500/mm3, platelets ? 100.000/mm3). Acceptable patients with alteration of transaminases ? 2.5 times normal limits, bilirubin total ? LSN, CPK? 2.5 times normal limits, alkalyne phosphatase ? 2.5 times more the normal limits or creatinine levels ? 1,6 mg/dL. 8. Patients in fertile age (both male and female) must use an effective contraceptive method before study entry and during the study. Furthermore, women must keep contraceptive measures until 3 months after finishing treatment while men must keep these measures up to 5 months after treatment. Pregnancy must be ruled out by urine test (negative pregnancy test) for inclusion in trial. 9. Normal cardiac functionality, considering the normal ranges of the institution. Are the trial subjects under 18? yes Number of subjects for this age range: 4 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 19 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Patients having been irradiated in the target lesions. 2. Functional state > 2 (ECOG). 3. Bilirubin levels superior to normal level. Creatinine superior to 1.6 mg/dL. 4. History of other tumor disease except basal-cell carcinoma or carcinoma in situ of cervix adequately treated. 5. Serious cardiovascular diseases (Dyspnea >= 2 NYHA). 6. Systemic pathologies limiting survival to less than 2 years, limiting the availability of the patient, or that may interfere significantly with the treatment toxicity. 7. Infectious diseases: bacterial, viral or mycotic not controlled. 8. Pregnant patients or nurturing. 9. Psychological, familiar, sociological or geographical situations not allowing the fulfilment of the protocol or informed consent. 10. Patients currenly included in another clinical trial or receiving any agent under investigation. 11. Patients having participated in a clinical trial and/or having received an agent in investigation in the 30 days previous to inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Analyze progression free survival (PFS), measured as SLP index at 4 months, in patients with metastatic osteosarcoma who have previously received the more active drugs in this disease (methotrexate, cisplatin, adriamycin and ifosfamide) and are in metastatic progression or cannot be operated.;Secondary Objective: Analyze the response rate (RECIST) of the study treatment (gemcitabine-rapamycin combination). Analyze the toxicity of the combination. Analyze the correlation with predictive biomarkers. Analyze the impact of the combination in overall survival.;Primary end point(s): Analyze progression-free survival (PFS), measured as SLP index at 4 months, in patients with metastatic osteosarcoma who have previously received the more active drugs in this disease (methotrexate, cisplatin, adriamycin and ifosfamide) and are in metastatic progression or cannot be operated.;Timepoint(s) of evaluation of this end point: 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Analyze the response rate (RECIST) of the study treatment (gemcitabine-rapamycin combination). 2. Analyze the toxicity of the combination. 3. Analyze the correlation with predictive biomarkers. 4. Analyze the impact of the combination in the overall survival.;Timepoint(s) of evaluation of this end point: 1. Continuously 2. Continuously 3. At the end of trial 4. Year 3 | — |
Countries
Spain
Contacts
Public ContactPatricio Ledesma
Sofpromed
Outcome results
None listed