Endostar + GT in Pulmonary Metastases of Soft Tissue Sarcoma

Soft Tissue Sarcoma Clinical Trial

Official title:

An Open-label, Single-arm, Phase II Study to Assess the Efficacy and Safety of Endostar® (Recombinant Human Endostatin Injection) Plus Gemcitabine and Docetaxel in Treatment of Soft Tissue Sarcoma Patients With Pulmonary Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01812018
• Other study ID #: CH-SAR-001
• Status: Recruiting
• Phase: Phase 2
• First received: March 13, 2013
• Last updated: March 13, 2013
• Start date: November 2012
• Est. completion date: October 2015

Study information

• Verified date: March 2013
• Source: Chinese Academy of Medical Sciences
• Contact: Peng Yuan, MD
• Phone: 86-10-8778-8114
• Email: yuanpeng01[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 be administered on Day 1 and Day 8 of each cycle. Docetaxel (75 mg/m2) will be administered on Day 2 of each cycle. An individual cycle of therapy will be defined as a 3-week (21-day) period. Cycles will be repeated every 3 weeks. Multiple cycles may be administered until the subject is PD or until a maximum of 6 cycles. Time-to-progression (TTP) will be assessed using the Kaplan Meier method. Overall response rate (ORR) as well as individual categories of response (CR, PR, SD, and PD) will be determined using RECIST (v1.1). Evaluation of 1- and 2-year overall survival will also be performed. Safety measures will be recorded using the NCI-CTCAE (v4.0).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Sarcoma
• Soft Tissue Sarcoma

Intervention

Drug:
• Endostar
Endostar administered at 7.5 mg/m2, intravenously (IV), on Day 1-14 every 21 days for up to 4-6 consecutive cycles
• Gemcitabine
Gemcitabine administered at 1000 mg/m2, intravenously (IV), on Day 1 and Day 8, every 21 days for up to 4-6 consecutive cycles
• Docetaxel
Docetaxel administered at 75 mg/m2, intravenously (IV), on Day 2, every 21 days for up to 4-6 consecutive cycles

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peng Yuan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-to-Progression	Time to progression is defined as time from first study treatment dose to the progression disease.	Approximately 2 years	No
Secondary	Overall Response Rate		Approximately 2 years	No
Secondary	Evaluate 1-year and 2-year overall survival rates		Approximately 2 years	No
Secondary	Safety measures	Adverse events, Clinical and laboratory data including physical examinations, vital signs, ECG results, Use of concomitant medications	Approximately 3 years	Yes