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A Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced Non Small Cell Lung Cancer Patients

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ClinicalTrials.gov Identifier: NCT01531790
Recruitment Status : Completed
First Posted : February 13, 2012
Last Update Posted : January 16, 2013
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Carboplatin Drug: Pemetrexed Drug: Endostar Drug: Centrum Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced NSCLC Patients
Study Start Date : September 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Endostar plus pemetrexed/carboplatin
21 days as one cycle, for a total of 4-6 cycles
 Drug: Carboplatin
d1, AUC 5, i.v.

Drug: Pemetrexed
d1, 500 mg/m2, i.v.

Drug: Endostar
d2-d21, continuous Endostar intravenous infusion, 7.5 mg/m2/d, 15 mg/m2/d or 30 mg/m2/d, etc.

Drug: Centrum
1 tablet/day


Outcome Measures
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Primary Outcome Measures :
  1. Dose Limiting Toxicity [ Time Frame: up to 21 days ]

Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: up to 6 cycles ]
  2. Disease Control Rate [ Time Frame: up to 6 cycles ]
  3. Progression-free Survival [ Time Frame: up to 2 years ]
  4. Overall Survival [ Time Frame: up to 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531790


Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Li Zhang, MD Sun Yat-sen University
More Information
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Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01531790    
Other Study ID Numbers: SIM-93
First Posted: February 13, 2012    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013
Keywords provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:
Endostar
Carboplatin
Pemetrexed
NSCLC
Phase I
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Pemetrexed
 Endostar protein
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors