Phase 2 study of gemcitabine and docetaxel chemotherapy for advanced bone and soft tissue sarcomas - GD therapy for advanced sarcomas

Hara Hitomi0 个研究点目标入组 20 人开始时间: 2019年1月30日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1)Patients are histopathologically diagnosed as the primary malignant tumor (sarcoma) of bone and soft tissue.
•2)Patients with advanced bone and soft tissue sarcoma having recurrence or metastasis.
•3)Patients who have previously received a standard therapy for bone and soft tissue sarcoma or could not receive a standard therapy.
•4)Patients who aged 10 to 70 years old at the time of enrollment.
•5)Patients who have a measurable evaluation lesion.
•6)Performance status (PS) is 0 or 1 in a standard of ECOG.
•7)Patients who have a primary tumor that appeared in extremity or trunk.
•8)Laboratory data within 14 days prior to enrollment meet all of the followings:
•1.Neutrophil more than 1,500 /mm3
•2.Hemoglobin more than 8.0 g/dL (there is no blood transfusion within 14 days)
•3.Platelet more than 100,000/mm3
•4.Total bilirubin less than 1.5 mg/dL
•5.AST(GOT) less than 100IU/L
•6.ALT(GPT) less than 100IU/L
•7.Creatinine less than 1.5 mg/dL
•8.Creatinine clearance (eGFR) more than 60 mL/min
•9)normal electrocardiogram within 28 days prior to enrollment
•10)Patients without interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema.
•11)Patients were given a written explanation of the study protocol and provided their written informed consent.

•1)Active double cancers within 5 years(cured intraepithelial carcinoma and intramucosal carcinoma are not included)
•2)Cases with complications of severe infection
•3) Patients who have hypersensitivity to study drugs
•4) Patients who have hypersensitivity to polysorbate 80
•5) Body temperature more than 38 degree
•6) Pregnant or breastfeeding women
•7) Severe psychological disease
•8) Patients who receive the continuous whole body dosage (or intravenous internal use) of steroid or other immunosuppressant
•9) Unstable angina (within 3 months after onset) , myocardial infarction
•10) Difficult-to-control hypertension
•11) Difficult-to-control diabetes
•12) HBs antigen is positive
•13) Judgment to attending physician

发起方

Hara Hitomi