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A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03100955
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
medley nie, Qingdao University

Brief Summary:
To establish the progression free survival in patients with extensive stage small cell lung cancer treated with cisplatin and etoposide plus or not apatinib

Condition or disease Intervention/treatment Phase
Progression Free Survival Drug: cisplatin, etoposide Drug: cisplatin, etoposide, apatinib Phase 3

Detailed Description:
Assess progression free survival, overall survival and toxicity of standard EP regimen combined or not with VEGF tyrosine kinase inhibitor-apatinib. Response measured by RECIST response criteria. Toxicity via physical exam, adverse event review, assessing signs and symptoms, quality of life assessment and blood testing.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : August 1, 2019


Arm Intervention/treatment
Active Comparator: EP chemotherapy
Standard treatment or active comparator group contains a platinum drug and a topoisomerase inhibitor. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatinum and etoposide.
Drug: cisplatin, etoposide
The recommended regimen is cisplatin plus etoposide. cisplatin 75 mg/m2 iv on day 1, etoposide 120 mg/m2 iv on day 1-3, 3 weeks a cycle, total for 6 cycles is allowed.

Experimental: EP chemotherapy plus apatinib
Apatinib treatment or experimental group contains standard chemotherapy and apatinib, a VEGF tyrosine kinase inhibitor. It contains a platinum drug, a topoisomerase inhibitor and a VEGF-TKI. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatinum and etoposide. Numbers of cycles 6. In addition to this, subjects will receive VEGF-TKI=apatinib, 500 mg, oral daily after chemotherapy, until disease progression or death or un-tolerated toxicites. Used drugs=cisplatinum and etoposide and apatinib.
Drug: cisplatin, etoposide, apatinib
Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatin and etoposide. Numbers of cycles 6. In addition to this, subjects will receive VEGF-TKI apatinib oral daily after chemotherapy treatment. Apatinib 500mg oral, once a day, until disease progression or death or un-tolerated toxicites.




Primary Outcome Measures :
  1. progression free survival [ Time Frame: 24 months ]
    from the date of randomization to disease progression



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically verified SCLC, extensive stages
  2. WHO performance status 0, 1, 2
  3. Age 18 years or older
  4. Treatment naive
  5. Anticipated survival more than 3 months
  6. HB >90g/L, ANC>1.5 x 109/L, Platelets >80 x109 /L
  7. No prognancy
  8. Signed informed consent

Exclusion Criteria:

  1. Limited stage disease
  2. Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm
  3. Uncontrolled hypertension
  4. Uncontrolled heart failure
  5. Coagulation problem
  6. Surgery, trauma, uncontrolled ulcer in 4 weeks.
  7. Required by physician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100955


Contacts
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Contact: keke nie, MD (86)18561857907 niekekeqd@163.com
Contact: youxin ji, MD, Ph. D (86)532-68665078 ji6677@gmail.com

Locations
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China, Shandong
Affiliated Hospital of Qingdao University Recruiting
Qingdao, Shandong, China, 266001
Contact: Zhuang Yu, MD    (86)18661805688    yuzhuang2002@163.com   
Principal Investigator: Zhuang Yu, MD, Ph.D         
Sponsors and Collaborators
Qingdao University
Investigators
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Study Chair: Zhuang Yu, MD, Ph. D Affiliated hospital of Qingdao University

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Responsible Party: medley nie, Secretary of clinical trials, Qingdao University
ClinicalTrials.gov Identifier: NCT03100955     History of Changes
Other Study ID Numbers: QU20170327
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Topoisomerase Inhibitors
Topoisomerase II Inhibitors
Enzyme Inhibitors
Protein Kinase Inhibitors
Small Cell Lung Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cisplatin
Etoposide
Etoposide phosphate
Apatinib
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action