A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Simcere Pharmaceutical Co., Ltd
Information provided by:
Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01028729
First received: December 7, 2009
Last updated: December 8, 2009
Last verified: December 2009
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Purpose
This single arm study will assess the safety and efficacy of Endostar combined with chemotherapy (Gemcitabine plus Platinum-based chemotherapy) followed by Endostar maintenance therapy in patients with stage IIIB/IV non-small cell lung cancer (NSCLC).
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer (NSCLC) |
Drug: Endostar Drug: Gemcitabine-Cisplatin chemotherapy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study of Endostar in Combination With Chemotherapy Followed by Endostar Maintenance Therapy in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) |
Resource links provided by NLM:
Further study details as provided by Simcere Pharmaceutical Co., Ltd:
Primary Outcome Measures:
- Progression Free Survival (PFS) [ Time Frame: July 2011 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective Response Rate (ORR) [ Time Frame: July 2011 ] [ Designated as safety issue: No ]
- Clinical Benefit Response (CBR) [ Time Frame: July 2011 ] [ Designated as safety issue: No ]
- Overall Survival (OS) [ Time Frame: July 2011 ] [ Designated as safety issue: No ]
- Survival Rate [ Time Frame: one year ] [ Designated as safety issue: No ]
- Adverse Events [ Time Frame: July 2011 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Endostar with chemotherapy
All eligible patients will receive Endostar in combination with Gemcitabine plus Platinum-based chemotherapy for 4 cycles (21 days for each cycle). Endostar treatment will continue after completion of chemotherapy cycles until disease progression.
|
Drug: Endostar
7.5mg/m2/day, iv, from day 1 to day 14
Other Name: Recombinant Human Endostatin Injection
Drug: Gemcitabine-Cisplatin chemotherapy
Gemcitabine 1000 mg/m2, iv, on day 1, 8 Cisplatin 80mg/m2, iv, on day 1, 2, 3
Other Name: GP chemotherapy
|
Detailed Description:
All eligible patients will receive Endostar in combination with Gemcitabine plus Platinum-based chemotherapy for 4 cycles (21 days for each cycle). Endostar treatment will continue after completion of chemotherapy cycles until disease progression. Efficacy will be evaluated every two cycles.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histological or cytological diagnosis of inoperable stage IIIB/IV NSCLC
- At least one measurable lesion
- Age of 18-75 years
- Life expectancy > 3 months
- ECOG performance status 0-2
- Adequate hematologic, renal, and hepatic function
Exclusion Criteria:
- Prior systemic chemotherapy for NSCLC
- Evidence of any unstable diseases (serious infection, grade 4 hypertension, unstable angina, congestive heart-failure, compromised renal or hepatic function, nonhealing wound or bone fracture)
- Concurrent anticoagulation therapy
- Evidence of bleeding diathesis or coagulopathy
- Pregnant or lactating women
- 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: NCT01028729
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028729
Contacts
| Contact: Yiping Zhang, Dr. | 86-0571-88122188 |
Locations
| China, Zhejiang | |
| Zhejiang Cancer Hospital | Recruiting |
| Hangzhou, Zhejiang, China, 310022 | |
| Contact: Yiping Zhang, Dr. 86-0571-88122188 | |
Sponsors and Collaborators
Simcere Pharmaceutical Co., Ltd
Investigators
| Principal Investigator: | Yiping Zhang, Dr. | Zhejiang Cancer Hospital |
More Information
No publications provided
| Responsible Party: | Jinsheng Ren, Simcere Pharmaceutical Co., Ltd |
| ClinicalTrials.gov Identifier: | NCT01028729 History of Changes |
| Other Study ID Numbers: | SIM090801 |
| Study First Received: | December 7, 2009 |
| Last Updated: | December 8, 2009 |
| Health Authority: | China: Ethics Committee |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Gemcitabine Anti-Infective Agents |
Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Antiviral Agents Enzyme Inhibitors Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Radiation-Sensitizing Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015