Know Cancer

or
forgot password

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


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Soft Tissue Sarcoma

Thank you

Trial Information

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


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).


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time-to-Progression

Outcome Description:

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

Outcome Time Frame:

Approximately 2 years

Safety Issue:

No

Principal Investigator

Peng Yuan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese Academy of Medical Sciences

Authority:

China: Food and Drug Administration

Study ID:

CH-SAR-001

NCT ID:

NCT01812018

Start Date:

November 2012

Completion Date:

October 2015

Related Keywords:

  • Soft Tissue Sarcoma
  • Soft Tissue Sarcoma
  • Pulmonary metastases
  • Neoplasm Metastasis
  • Lung Neoplasms
  • Sarcoma

Name

Location