Description:
The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer
treatments. Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular
endothelial growth factor receptor-2 (VEGFR-2). Etoposide is an oral preparation for lung
cancer which is recommended by NCCN guideline. The investigators wondered whether these two
drugs have synergistic effects when treating advanced non-small cell lung cancer patients who
failed to previous at least 2nd line treatments. Thus, the aim of this trial is to
investigate the efficacy and safety of apatinib combined with etoposide in heavily pretreated
advanced non-small cell lung cancer.
Title
- Brief Title: The Efficacy and Safety of Apatinib Combined With Etoposide in Heavily Pretreated Advanced Non-small Cell Lung Cancer
- Official Title: The Efficacy and Safety of Apatinib Combined With Etoposide in Advanced Non-small Cell Lung Cancer Patients Failed to Previous at Least 2rd Line Treatments
Clinical Trial IDs
- ORG STUDY ID:
ACEL
- NCT ID:
NCT02733107
Conditions
- Non-small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
Apatinib | | Apatinib+Etoposide |
Etoposide | VP-16 | Apatinib+Etoposide |
Purpose
The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer
treatments. Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular
endothelial growth factor receptor-2 (VEGFR-2). Etoposide is an oral preparation for lung
cancer which is recommended by NCCN guideline. The investigators wondered whether these two
drugs have synergistic effects when treating advanced non-small cell lung cancer patients who
failed to previous at least 2nd line treatments. Thus, the aim of this trial is to
investigate the efficacy and safety of apatinib combined with etoposide in heavily pretreated
advanced non-small cell lung cancer.
Trial Arms
Name | Type | Description | Interventions |
---|
Apatinib+Etoposide | Other | Apatinib combined with Etoposide | |
Eligibility Criteria
Inclusion Criteria:
- Obtain of informed consent.
- Histologically or cytologically confirmed non-small cell lung cancer.
- World Health Organization (WHO) performance status (PS) of 0 to 2.
- Measurable lesions as defined by RECIST criteria.
- Second-line or more treatments.
- Wild type of epidermal-growth-factor receptor (EGFR).
- Life expectancy ≥12 weeks.
- Organ functions normal, as defined below, within two weeks of randomization:
• Hb≥90g/L Absolute neutrophils count(ANC)≥1.5×109/L Platelets≥80×109/L Serum
bilirubin≤2×ULN; Aspartate transaminase(AST) and alanine transaminase
(ALT)≤2.5×ULN(≤5×ULN if liver metastases) Creatinine clearance≥45ml/min or
Cr≤1.25×ULN.
- Females of child-bearing potential must have negative serum pregnancy test.
- Sexually active males and females (of childbearing potential) willing to practice
contraception during the study.
Exclusion Criteria:
- Small cell lung cancer.
- Newly diagnosed Central Nervous System (CNS) metastases that have not yet been
definitively treated with surgery and/or radiation.
- Uncontrolled hypertension.
- Myocardial ischemia or infarction more than stage II, cardiac insufficiency.
- Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or
receiving coagulation therapy.
- Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic
bacillary diarrhea and intestinal obstruction).
- Hemoptysis, more than 2.5ml daily.
- Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous
thrombosis.
- Unhealed bone fracture or wound for long time.
- Received big surgery, had bone fracture or ulcer in 4 weeks.
- Urine protein≥++, or urine protein in 24 hours≥1.0g.
- Pregnant or lactating woman.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression free survival |
Time Frame: | evaluated in 24 months since the treatment began |
Safety Issue: | |
Description: | the first day of treatment to the date that disease progression is reported |
Secondary Outcome Measures
Measure: | Objective Response Rate |
Time Frame: | tumor assessment every 6-8 weeks since the treatment began,up to 24 months |
Safety Issue: | |
Description: | the ratio between the number of responders and number of patients assessable for tumor response |
Measure: | Overall survival |
Time Frame: | the first day of treatment to death or last survival confirm date,up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Side effects |
Time Frame: | evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Third Military Medical University |
Trial Keywords
- Non-small Cell Lung Cancer
- Apatinib
- Etoposide
Last Updated
April 12, 2016