A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma

This study is currently recruiting participants.
Verified July 2011 by Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
Sponsor:
Information provided by:
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01002092
First received: October 25, 2009
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

Purpose: This study will assess the safety and efficacy of Endostar combined with chemotherapy in osteosarcoma patients.


Condition Intervention Phase
Osteosarcoma
Drug: Chemotherapy
Drug: Endostar
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Multicenter Trial of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma

Resource links provided by NLM:


Further study details as provided by Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Limb Salvage Rate [ Time Frame: end of the first cycle ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Clinical Response Rate [ Time Frame: end of the first cycle ] [ Designated as safety issue: No ]
  • Clinical Benefit Response [ Time Frame: end of the first cycle ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: after 4 cycles ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: February 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chemotherapy Drug: Chemotherapy
Week 1 day 1 MTX 8 g/m2; Week 3 day 1-2 CDP 100-120 mg/m2 day 1 ADM/THP 60 mg/m2; Week 5 day 1-6 IFO 2 g/day; Week 7 rest; Week 8 surgery; Two weeks after the surgery repeat the chemotherapy cycle 3 times (6 weeks per cycle).
Experimental: Endostar plus Chemotherapy Drug: Chemotherapy
Week 1 day 1 MTX 8 g/m2; Week 3 day 1-2 CDP 100-120 mg/m2 day 1 ADM/THP 60 mg/m2; Week 5 day 1-6 IFO 2 g/day; Week 7 rest; Week 8 surgery; Two weeks after the surgery repeat the chemotherapy cycle 3 times (6 weeks per cycle).
Drug: Endostar
In each cycle, Week 1-2 day 1-14 endostar 7.5 mg/m2/day; Week 5-6 day 1-14 endostar 7.5 mg/m2/day

  Eligibility

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically confirmed osteosarcoma, who have no evidence of metastasis
  • At least one measurable lesion
  • Life expectancy > 3 months
  • ECOG performance status 0-2
  • Adequate hematologic, cardiac, renal, and hepatic function
  • Patients with prior chemotherapy should have at least 4 weeks clearance period before entering this study

Exclusion Criteria:

  • Evidence of metastasis
  • Serious infection
  • Evidence of bleeding diathesis
  • Significant cardiovascular disease
  • Pregnant or lactating woman
  • Allergic to E.coli preparation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002092

Contacts
Contact: Sujia Wu, Dr. wusujia@yahoo.com.cn
Contact: Xin Shi, Dr. shixin2k@vip.163.com

Locations
China, Jiangsu
Nanjing General Hospital of Nanjing Military Command Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Sujia Wu, Dr.       wusujia@yahoo.com.cn   
China, Shandong
General Hospital of Jinan Military Command Recruiting
Jinan, Shandong, China, 250031
Contact: Xiuchun Yu, Dr.       yxch36@yahoo.com.cn   
China, Shanxi
Xijing Hospital Recruiting
Xi'an, Shanxi, China, 710032
Contact: Zhen Wang, Dr.       wangzhen@fmmu.edu.cn   
China
The Military General Hospital of Beijing PLA Recruiting
Beijing, China, 100700
Contact: Tiansheng Sun, Dr.         
Sponsors and Collaborators
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
Investigators
Principal Investigator: Sujia Wu, Dr. Nanjing PLA General Hospital
Principal Investigator: Xin Shi, Dr. Nanjing PLA General Hospital
  More Information

No publications provided

Responsible Party: Jinsheng Ren, Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01002092     History of Changes
Other Study ID Numbers: SIM-65
Study First Received: October 25, 2009
Last Updated: July 20, 2011
Health Authority: China: Ethics Committee

Keywords provided by Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd:
Osteosarcoma
Endostar
Chemotherapy

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma

ClinicalTrials.gov processed this record on April 22, 2014