A Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced Non Small Cell Lung Cancer Patients
A Phase I Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced NSCLC Patients
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 nonsmall-cell-lung-cancer
Started Sep 2011
Shorter than P25 for phase_1 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 7, 2012
CompletedFirst Posted
Study publicly available on registry
February 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJanuary 16, 2013
January 1, 2013
1.3 years
February 7, 2012
January 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose Limiting Toxicity
up to 21 days
Secondary Outcomes (4)
Objective Response Rate
up to 6 cycles
Disease Control Rate
up to 6 cycles
Progression-free Survival
up to 2 years
Overall Survival
up to 2 years
Study Arms (1)
Endostar plus pemetrexed/carboplatin
EXPERIMENTAL21 days as one cycle, for a total of 4-6 cycles
Interventions
d2-d21, continuous Endostar intravenous infusion, 7.5 mg/m2/d, 15 mg/m2/d or 30 mg/m2/d, etc.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li Zhang, MD
Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2012
First Posted
February 13, 2012
Study Start
September 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
January 16, 2013
Record last verified: 2013-01