Endostar + GT in Pulmonary Metastases of Soft Tissue Sarcoma

NCT01812018 | Unknown Phase 2

• 1 other identifier: CH-SAR-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 soft tissue sarcoma patients with pulmonary metastases.

Conditions

Soft Tissue Sarcoma

Keywords

Soft Tissue Sarcoma; Pulmonary metastases

Outcome Measures

Primary Outcomes (1)

• Time-to-Progression

  Time to progression is defined as time from first study treatment dose to the progression disease.

  Approximately 2 years

Secondary Outcomes (3)

• Overall Response Rate

  Approximately 2 years

• Evaluate 1-year and 2-year overall survival rates

  Approximately 2 years

• Safety measures

  Approximately 3 years

Study Arms (1)

Endostar

EXPERIMENTAL

Endostar, Gemcitabine, Docetaxel

Drug: Endostar; Drug: Gemcitabine; Drug: Docetaxel

Interventions

Endostar DRUG

Endostar administered at 7.5 mg/m2, intravenously (IV), on Day 1-14 every 21 days for up to 4-6 consecutive cycles

Also known as: Recombinant Human Endostatin Injection

Endostar

Gemcitabine DRUG

Gemcitabine administered at 1000 mg/m2, intravenously (IV), on Day 1 and Day 8, every 21 days for up to 4-6 consecutive cycles

Endostar

Docetaxel DRUG

Docetaxel administered at 75 mg/m2, intravenously (IV), on Day 2, every 21 days for up to 4-6 consecutive cycles

Endostar

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peng Yuan: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

endostar protein; Endostatins; Gemcitabine; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Peng Yuan, MD

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Yuan, MD

CONTACT

86-10-8778-8114; yuanpeng01@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: March 15, 2013
• Study Start: November 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 15, 2013

Record last verified: 2013-03

Locations

CN (1)