EUCTR2012-001106-26-ES进行中（未招募）不适用
PHASE II MULTICENTRIC AND PROSPECTIVE TRIAL WITH GEMCITABINE AND RAPAMYCIN IN SECOND LINE OF METASTATIC OSTEOSARCOMA - OSTEOSARCOMA METASTASICO PREVIOUSLY TREATED
JAVIER MARTÍN BROTO0 个研究点开始时间: 2012年4月17日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
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