- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02875457
Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide/Cisplatin
August 23, 2016 updated by: Dong Wang, Third Military Medical University
A Randomized Controlled Study of Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide and Cisplatin Chemotherapy
Apatinib has been approved as a second-line treatment for advanced gastric cancer.
Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance.
However, the clinical application of apatinib in small cell lung cancer is still lack of evidence-based medicine.
Etoposide and cisplatin chemotherapy is the first-line treatment for small-cell lung cancer.
The purpose of this multicenter, randomized, prospective study is to investigate the efficacy and safety of apatinib as the maintenance therapy for extensive stage small cell lung cancer after combined with etoposide and cisplatin chemotherapy.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wang Dong, PH.D.
- Phone Number: 86-23-68757151
- Email: dongwang64@hotmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologic or cytologic diagnosis of small cell lung caner(SCLC), Extensive Stage.
- No prior cisplatin-based chemotherapy or radiotherapy.
- Males or females between 18 Years to 75 Years.
- Performance status of 0~2 on the ECOG criteria.
- Expected survival is above three months.
- At least one measurable lung tumor lesion (according to RECIST criteria, the application of conventional technology, diameter length of the lesion >= 20mm or spiral CT >=10mm).
- Adequate hematologic (Leukocyte count >= 4.0×109/L, neutrophil count>=2.0×109/L, hemoglobin>=95g/L, platelets>=100×109/L), hepatic function (aspartate transaminase (AST) & alanine transaminase(ALT) =<upper normal limit(UNL) x1.5, bilirubin level =< UNL x 1.5).
- Patient can take oral medicine.
- Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.
Exclusion Criteria:
- History of cardiovascular disease: congestive heart failure (CHF) > New York Heart Association (NYHA) II, active coronary artery disease(patients with myocardial infarction six months ago can be recruited), arrhythmias need to be treated (allow taking beta blockers or digoxin).
- Serious clinical infection (> NCI-CTCAE version 4.0 ,infection standard II).
- Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).
- with brain metastases.
- The patients had accepted allogeneic organ transplantation.
- Bleeding tendency or coagulation disorders.
- patients who need renal dialysis.
- suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor).
- uncontrolled hypertension (systolic pressure>150 mmHg , or diastolic pressure> 90 mmHg).
- thrombosis or embolism(cerebrovascular accidents including transient ischemic attack within the last 6 months).
- pulmonary hemorrhage >CTCAE grade 2 within 4 weeks before first use of drugs.
- Other organ hemorrhage >CTCAE grade 3 within 4 weeks before first use of drugs.
- severe uncured wounds, ulcers or fracture.
- uncured dehydration.
- Drugs abuse and medical, psychological or social conditions may interfere with the patient's participation in research or the results of the evaluation effect.
- Patients are allergic to drugs used in research.
- Factors influencing the safety and compliance of patients.
- Inability to comply with protocol or study procedures.
- Pregnant or breast-feeding.
- The researcher believe that the Patient is not suitable to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A
Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, and apatinib 250mg/d , repeated every 21 days, a total of 6 cycles, and then continue to take apatinib 250mg/d until progressive Disease(PD).
|
|
Placebo Comparator: Arm B
Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, and placebo, repeated every 21 days, a total of 6 cycles, and then continue to take placebo until PD.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: 6 months
|
The first day of treatment to the date that disease progression is reported.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor response rate
Time Frame: 3 months
|
The ratio between the number of responders and number of patients assessable for tumor response.
|
3 months
|
Overall survival
Time Frame: 5 years
|
The first day of treatment to death or last survival confirm date.
|
5 years
|
Treatment-related adverse events
Time Frame: the first date of treatment to 30 days after the last dose of study drug,assessed up to 6 months
|
Treatment-related adverse events are assessed by common terminology criteria for adverse events(CTCAE) V4.0.
|
the first date of treatment to 30 days after the last dose of study drug,assessed up to 6 months
|
Performance Status
Time Frame: the first date of treatment to 30 days after the last dose of study drug, assessed up to 6 months
|
Performance Status of patients will be assessed by Zubrod-Eastern cooperative oncology group(ECOG)-world health organization(WHO).
|
the first date of treatment to 30 days after the last dose of study drug, assessed up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wang Dong, PH.D., Daping Hospital, Third Military Medical University, Chongqing,China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Anticipated)
September 1, 2018
Study Completion (Anticipated)
September 1, 2023
Study Registration Dates
First Submitted
June 11, 2016
First Submitted That Met QC Criteria
August 17, 2016
First Posted (Estimate)
August 23, 2016
Study Record Updates
Last Update Posted (Estimate)
August 24, 2016
Last Update Submitted That Met QC Criteria
August 23, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Protein Kinase Inhibitors
- Etoposide
- Etoposide phosphate
- Cisplatin
- Apatinib
Other Study ID Numbers
- AEP-ES-SCLC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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