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.
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01531790
First received: February 7, 2012
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Non-Small Cell Lung Cancer
Drug: Carboplatin
Drug: Pemetrexed
Drug: Endostar
Drug: Centrum
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:

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 ]

Enrollment: 19
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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: NCT01531790

Locations
China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Li Zhang, MD Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01531790     History of Changes
Other Study ID Numbers: SIM-93
Study First Received: February 7, 2012
Last Updated: January 15, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:
Endostar
Carboplatin
Pemetrexed
NSCLC
Phase I

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on August 01, 2014