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:
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
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
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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 |
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 May 19, 2013