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Endostar + GT in Pulmonary Metastases of Soft Tissue Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01812018
Recruitment Status : Unknown
Verified March 2013 by Peng Yuan, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : March 15, 2013
Last Update Posted : March 15, 2013
Sponsor:
Information provided by (Responsible Party):
Peng Yuan, Chinese Academy of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Drug: Endostar Drug: Gemcitabine Drug: Docetaxel Phase 2

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 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2012
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : October 2015


Arm Intervention/treatment
Experimental: Endostar
Endostar, Gemcitabine, Docetaxel
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
Other Name: Recombinant Human Endostatin Injection

Drug: 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

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




Primary Outcome Measures :
  1. Time-to-Progression [ Time Frame: Approximately 2 years ]
    Time to progression is defined as time from first study treatment dose to the progression disease.


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Approximately 2 years ]
  2. Evaluate 1-year and 2-year overall survival rates [ Time Frame: Approximately 2 years ]
  3. Safety measures [ Time Frame: Approximately 3 years ]
    Adverse events, Clinical and laboratory data including physical examinations, vital signs, ECG results, Use of concomitant medications



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812018


Contacts
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Contact: Peng Yuan, MD 86-10-8778-8114 yuanpeng01@hotmail.com

Locations
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China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China, 100021
Contact: Peng Yuan, MD    86-10-8778-8114    yuanpeng01@hotmail.com   
Principal Investigator: Peng Yuan, MD         
Sponsors and Collaborators
Peng Yuan
Investigators
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Principal Investigator: Peng Yuan, MD Chinese Academy of Medical Sciences

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Responsible Party: Peng Yuan, Associate Chief Physician, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01812018    
Other Study ID Numbers: CH-SAR-001
First Posted: March 15, 2013    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: March 2013
Keywords provided by Peng Yuan, Chinese Academy of Medical Sciences:
Soft Tissue Sarcoma
Pulmonary metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Sarcoma
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gemcitabine
Docetaxel
Endostar protein
Endostatins
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors