Status:
UNKNOWN
Endostar + GT in Pulmonary Metastases of Soft Tissue Sarcoma
Lead Sponsor:
Peng Yuan
Conditions:
Soft Tissue Sarcoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this exploratory phase II study is to assess the effectiveness and safety profile of Endostar®(Recombinant Human Endostatin Injection) plus Gemcitabine and Docetaxel in treatment of sof...
Detailed Description
Anticipated 30 subjects will be enrolled to receive Endostar, Gemcitabine and Docetaxel. Endostar at a dosage of 7.5 mg/m2 will be administered on Day 1-14 of each cycle. Gemcitabine (1000 mg/m2) will...
Eligibility Criteria
Inclusion
- Age between 18-70 years, male or female.
- ECOG performance status \<=2.
- Life expectancy \>= 3 months.
- Histologically or cytologically confirmed soft tissue sarcoma (GIST excluded).
- Patients must have had a prior anthracycline and/or ifosfamide in either the adjuvant or metastatic setting but not more than one regimen.
- At least one measurable pulmonary metastasis tumor lesions according to RECIST 1.1 criteria.
- Laboratory values: Hemoglobin (Hb) \>= 90 g/L and no blood transfusion within 14 days, Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L, Platelet (Plt)\>= 80 x 10\^9/L, Total Bilirubin (Tbil)=\< 1.5 x upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x ULN or =\< 5 x ULN if liver metastases are present, Serum creatinine (Cr) =\< 1.0 x ULN, Endogenous creatinine clearance (Ccr)\> 50 mL/min (Cockcroft-Gault).
- Women of child bearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment and be willing to use effective contraception during study and for 8 weeks after last IMP administration.
- Willingness to participate in study and sign informed consent form.
Exclusion
- Females who are pregnant or breastfeeding or have Childbearing potential unwilling to use effective contraception.
- Prior therapy with Gemcitabine, Docetaxel and Endostar.
- Subjects participating in other clinical trials within 4 weeks before enrollment.
- Accompanied by rapid progress of organ invasions, e.g.lesion areas are great than one half of liver or lung or have liver dysfunction.
- Uncontrolled central nervous system disorder or psychiatric illness.
- Current, serious, clinically significant cardiac arrhythmias, symptomatic congestive heart failure, myocardial infarction before enrollment.
- Patients with abnormal bone marrow function: ANC \< 1.5 x 10\^9/L, Plt \< 75 x 10\^9/L, Hb \< 90g/L.
- Patients with renal dysfunction: Cr \> 1.5 x ULN.
- Patients with liver dysfunction: Tbil \> 1.5 x ULN.
- Uncontrolled brain metastases.
- Unwillingness or inability to comply with the study protocol.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01812018
Start Date
November 1 2012
End Date
October 1 2015
Last Update
March 15 2013
Active Locations (1)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021