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A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma

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: NCT01002092
Recruitment Status : Unknown
Verified August 2014 by Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd.
Recruitment status was:  Active, not recruiting
First Posted : October 27, 2009
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd

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

Condition or disease Intervention/treatment Phase
Osteosarcoma Drug: Chemotherapy Drug: Endostar Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Multicenter Trial of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
Study Start Date : February 2009
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Limb Salvage Rate [ Time Frame: end of the first cycle ]
  2. Overall Survival [ Time Frame: 5 years ]
  3. Clinical Response Rate [ Time Frame: end of the first cycle ]
  4. Clinical Benefit Response [ Time Frame: end of the first cycle ]
  5. Quality of Life [ Time Frame: after 4 cycles ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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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): NCT01002092


Locations
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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
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Principal Investigator: Sujia Wu, Dr. Nanjing PLA General Hospital
Principal Investigator: Xin Shi, Dr. Nanjing PLA General Hospital
More Information
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Responsible Party: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01002092    
Other Study ID Numbers: SIM-65
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: August 2014
Keywords provided by Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd:
Osteosarcoma
Endostar
Chemotherapy
Additional relevant MeSH terms:
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Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
 Endostar protein
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents