A Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced Non Small Cell Lung Cancer Patients
This study has been completed.
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.
First received: February 7, 2012
Last updated: January 15, 2013
Last verified: January 2013
This study is to evaluate the safety, tolerability, clinical efficacy and pharmacokinetics of continuous Endostar intravenous infusion combined with pemetrexed and carboplatin in advanced non small cell lung cancer (NSCLC) patients.
Non-Small Cell Lung Cancer
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase I Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced NSCLC Patients
Primary Outcome Measures:
- Dose Limiting Toxicity [ Time Frame: up to 21 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Objective Response Rate [ Time Frame: up to 6 cycles ] [ Designated as safety issue: No ]
- Disease Control Rate [ Time Frame: up to 6 cycles ] [ Designated as safety issue: No ]
- Progression-free Survival [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
Experimental: Endostar plus pemetrexed/carboplatin
21 days as one cycle, for a total of 4-6 cycles
d1, AUC 5, i.v.
d1, 500 mg/m2, i.v.
d2-d21, continuous Endostar intravenous infusion, 7.5 mg/m2/d, 15 mg/m2/d or 30 mg/m2/d, etc.
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Histological or cytological diagnosis of inoperable stage IIIB/IV non-squamous NSCLC
- 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
- With uncontrollable malignant pleural effusion or ascites
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01531790
|Sun Yat-sen University Cancer Center
|Guangzhou, Guangdong, China |
Jiangsu Simcere Pharmaceutical Co., Ltd.
||Li Zhang, MD
||Sun Yat-sen University
No publications provided
||Jiangsu Simcere Pharmaceutical Co., Ltd.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 7, 2012
||January 15, 2013
||China: Food and Drug Administration
Keywords provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2015
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action