advanced bone and soft tissue sarcomas
Conditions
Interventions
Gemcitabine (900 mg/m2) intravenously(IV) on Day 1 and Day 8, and docetaxel (70 mg/m2) IV on Day 8, repeated every 3 weeks until progression disease.
Sponsors
Kobe University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 1)Active double cancers within 5 years(cured intraepithelial carcinoma and intramucosal carcinoma are not included) 2)Cases with complications of severe infection 3)Body temperature more than 38 degree 4)Pregnant or breastfeeding women 5)Severe psychological disease 6) 7)Unstable angina (within 3 months after onset) , myocardial infarction 8)Difficult-to-control hypertension 9)Difficult-to-control diabetes 10)HBs antigen is positive 11)Judgment to attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate, disease control rate, incidence rate of adverse event, overall survival | — |
Countries
Japan
Contacts
Public ContactHitomi Hara
Kobe University Graduate School of Medicine Department of Orthopaedic Surgery
Outcome results
None listed