Etoposide-Carboplatin Alone or With Endostar for Extensive Disease Small Cell Lung Cancer (ED-SCLC)
Etoposide-Carboplatin (EC) Versus EC Plus Endostar in Patients With Extensive Disease Small Cell Lung Cancer (ED-SCLC): Randomized, Open Label, Placebo-controlled, Multicentre Study
1 other identifier
interventional
138
1 country
1
Brief Summary
Background: The effect of existing treatment modalities of extensive disease small-cell lung cancer (ED-SCLC) is unsatisfactory. Progress of new strategies including more efficient therapy is wanted. Endostar® (Rh-endostatin Injection) may have anti-tumor activity by against vascular endothelial growth factor for initial treatment. This study was designed to evaluate the safety and efficacy of Endostar® combined with etoposide-carboplatin (EC) chemotherapy in patients with ED-SCLC seeking for more effective treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 1, 2009
CompletedFirst Posted
Study publicly available on registry
June 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedSeptember 3, 2014
August 1, 2014
3.6 years
June 1, 2009
August 31, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS)
Oct-30-2012
Secondary Outcomes (7)
Progression free survival
at 6 months
Overall survival (OS)
Oct-30-2012
Objective response rate (ORR)
Oct-30-2012
Clinical benefit rate (CBR)
Oct-30-2012
Response duration
Oct-30-2012
- +2 more secondary outcomes
Study Arms (2)
Etoposide-Carboplatin with Endostar
EXPERIMENTALEndostar® 7.5mg/m2 on day 1 to day 14, etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.
Etoposide-Carboplatin
ACTIVE COMPARATOREtoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.
Interventions
Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically diagnosed SCLC;
- Age of 18-75 years;
- Life expectancy \> 3 months;
- Adequate hematologic, renal, and hepatic function;
- ECOG PS 0-2;
You may not qualify if:
- Brain metastases;
- Clinically significant cardiovascular disease;
- Presence of hepatic and renal dysfunction;
- Evidence of bleeding diathesis or coagulopathy
- Pregnant or lactating woman;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200039, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shun Lu, Dr.
Shanghai Chest Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2009
First Posted
June 3, 2009
Study Start
May 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
September 3, 2014
Record last verified: 2014-08