A Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced Non Small Cell Lung Cancer Patients
NCT ID: NCT01531790
Last Updated: 2013-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
19 participants
INTERVENTIONAL
2011-09-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endostar plus pemetrexed/carboplatin
21 days as one cycle, for a total of 4-6 cycles
Carboplatin
d1, AUC 5, i.v.
Pemetrexed
d1, 500 mg/m2, i.v.
Endostar
d2-d21, continuous Endostar intravenous infusion, 7.5 mg/m2/d, 15 mg/m2/d or 30 mg/m2/d, etc.
Centrum
1 tablet/day
Interventions
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Carboplatin
d1, AUC 5, i.v.
Pemetrexed
d1, 500 mg/m2, i.v.
Endostar
d2-d21, continuous Endostar intravenous infusion, 7.5 mg/m2/d, 15 mg/m2/d or 30 mg/m2/d, etc.
Centrum
1 tablet/day
Eligibility Criteria
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Inclusion Criteria
* At least one measurable lesion (RECIST criteria)
* Life expectancy \> 3 months
* ECOG performance status 0-2
* Adequate hematologic function: WBC ≥ 3.0×109 /L，ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L
* Adequate renal, hepatic and coagulation function
* Written informed consent
Exclusion Criteria
* Thoracic or abdominal surgery within 28 days prior to study entry
* History of cerebral stroke or TIA within 6 months prior to study entry
* With uncontrollable hypertension, hypertensive emergency or hypertensive encephalopathy
* Arrhythmia in need of antiarrhythmic treatment, history of angina pectoris, myocardial infarction, myocardial ischemia or congestive heart failure (\> NYHA class II)
* With serious infection (\> NCI CTC grade 2)
* Gastrointestinal perforation, fistula formation, and/or intra-abdominal abscess within 6 months prior to study entry
* Symptomatic brain metastases
* Patient who has epilepsy
* History of HIV infection or chronic hepatitis B or C
* Allergic to any of the study drugs
* Pregnant or lactating women
18 Years
70 Years
ALL
No
Sponsors
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Jiangsu Simcere Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Li Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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SIM-93
Identifier Type: -
Identifier Source: org_study_id
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