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

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:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Carboplatin Pemetrexed Pemetrexed disodium

U.S. FDA Resources

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 (Adult, Senior)
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


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:


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 Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016