Japanease

Jan. 30, 2019

Jan. 30, 2019

jRCTs051180042

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

GD therapy for advanced sarcomas (GD therapy for advanced sarcomas)

Hara Hitomi

Kobe University Hospital

7-5-2, Kusunoki-cho, Chuo-ku, Kobe city

+81-78-382-5985

mitohi@med.kobe-u.ac.jp

Hara Hitomi

Kobe University Hospital

7-5-2, Kusunoki-cho, Chuo-ku, Kobe city

+81-78-382-5895

mitohi@med.kobe-u.ac.jp

Mar. 20, 2018

20

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

none

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

10age old
70age old

Both

advanced pretreated bone and soft tissue sarcomas

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.

progression free survival

objective response rate, disease control rate, incidence rate of adverse event, overall survival

Recruiting

Kobe University Clinical Research Ethical Committee
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo

+81-78-382-6669

cerb@med.kobe-u.ac.jp
Approval

Dec. 03, 2018

UMIN000031004
UMIN Clinical Trials Registry (UMIN-CTR)