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Endostar + GT in Pulmonary Metastases of Soft Tissue Sarcoma

Primary Purpose

Soft Tissue Sarcoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Endostar

Gemcitabine

Docetaxel

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring Soft Tissue Sarcoma, Pulmonary metastases

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endostar

Arm Description

Endostar, Gemcitabine, Docetaxel

Outcomes

Primary Outcome Measures

Time-to-Progression

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

Secondary Outcome Measures

Overall Response Rate

Evaluate 1-year and 2-year overall survival rates

Safety measures

Adverse events, Clinical and laboratory data including physical examinations, vital signs, ECG results, Use of concomitant medications

Full Information

NCT ID

NCT01812018

First Posted

March 13, 2013

Last Updated

March 13, 2013

Sponsor

Peng Yuan

1. Study Identification

Unique Protocol Identification Number

NCT01812018

Brief Title

Endostar + GT in Pulmonary Metastases of Soft Tissue Sarcoma

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 Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

November 2012 (undefined)

Primary Completion Date

April 2015 (Anticipated)

Study Completion Date

October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Peng Yuan

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Soft Tissue Sarcoma

Keywords

Soft Tissue Sarcoma, Pulmonary metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Endostar

Arm Type

Experimental

Arm Description

Endostar, Gemcitabine, Docetaxel

Intervention Type

Drug

Intervention Name(s)

Endostar

Other Intervention Name(s)

Recombinant Human Endostatin Injection

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

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

Primary Outcome Measure Information:

Title

Time-to-Progression

Description

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

Time Frame

Approximately 2 years

Secondary Outcome Measure Information:

Title

Overall Response Rate

Time Frame

Approximately 2 years

Title

Evaluate 1-year and 2-year overall survival rates

Time Frame

Approximately 2 years

Title

Safety measures

Description

Adverse events, Clinical and laboratory data including physical examinations, vital signs, ECG results, Use of concomitant medications

Time Frame

Approximately 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peng Yuan, MD

Phone

86-10-8778-8114

yuanpeng01@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peng Yuan, MD

Organizational Affiliation

Chinese Academy of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

City

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peng Yuan, MD

Phone

86-10-8778-8114

yuanpeng01@hotmail.com

First Name & Middle Initial & Last Name & Degree

Peng Yuan, MD

12. IPD Sharing Statement

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Endostar + GT in Pulmonary Metastases of Soft Tissue Sarcoma

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