Endostar + GT in Pulmonary Metastases of Soft Tissue Sarcoma

• Status: Unknown status
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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 soft tissue sarcoma patients with pulmonary metastases.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peng Yuan
• Treatments: Docetaxel; Endostar protein; Endostatins; Gemcitabine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.