A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01002092
First received: October 25, 2009
Last updated: August 31, 2014
Last verified: August 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002092

Locations
China, Jiangsu
Nanjing General Hospital of Nanjing Military Command
Nanjing, Jiangsu, China, 210002
China, Shandong
General Hospital of Jinan Military Command
Jinan, Shandong, China, 250031
China, Shanxi
Xijing Hospital
Xi'an, Shanxi, China, 710032
China
The Military General Hospital of Beijing PLA
Beijing, China, 100700
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: 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: August 31, 2014
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 September 29, 2014