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Sequential Use of Low-dose Sunitinib With Chemotherapy in Advanced NSCLC After Failure of Conventional Regimen

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ClinicalTrials.gov Identifier: NCT01850147
Recruitment Status : Unknown
Verified May 2013 by LI Junling, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : May 9, 2013
Last Update Posted : May 9, 2013
Sponsor:
Information provided by (Responsible Party):
LI Junling, Chinese Academy of Medical Sciences

Brief Summary:
The purpose of this study is to determine whether sequential application of low-dose short-term sunitinib and chemotherapy is effective in the treatment of non-small cell lung cancer after failure of conventional therapy. Safety of this regimen will also be evaluated.

Condition or disease Intervention/treatment Phase
Cancer Lung Cancer Drug: Sunitinib, chemotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Efficacy and Safety of Sequential Low-dose Sunitinib With Chemotherapy in Advanced Non-small Cell Lung Cancer After Failure of Conventional Regimen
Study Start Date : March 2013
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sunitinib Drug: Sunitinib, chemotherapy
sunitinib, 12.5mg/day, for 7 days before each cycle of chemotherapy; chemotherapy, single agent including docetaxel, albumin-bound paclitaxel, vinorelbine, gemcitabine, pemetrexed, or paclitaxel, as determined by the investigator




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: up to 2 years ]
    The primary objective of this study is to evaluate the median progression-free survival of this sequential regimen.


Secondary Outcome Measures :
  1. overall survival [ Time Frame: up to 2 years ]
    To evaluate the median over-all survival of this regimen

  2. disease control rate [ Time Frame: up to 6 months ]
    To evaluate the disease-control rate of this regimen.

  3. Safety [ Time Frame: up to 2 years ]
    To evaluate the safety of this regimen including the rate and grade of adverse effects.



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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:

  • Histologic or cytologic diagnosis of stage IIIB/IV NSCLC
  • ECOG PS: 0,1
  • Unidimensional or bi-dimensional measurable disease
  • Receive prior treatment including first-line platinum-based chemotherapy, standard second-line chemotherapy and 1 EGF/EGFR inhibitor
  • Evidence of disease progression
  • Life expectancy >12 weeks
  • Neutrophils > 1.5 109/l, Platelets > 100 109/l, Hemoglobin > 9g/dl, Total bilirubin < 1.5 UNL, AST (SGOT) and ALT (SGPT) < 2.5 UNL, Alkaline phosphatases < 5 UNL, Creatinine < 1 UNL

Exclusion Criteria:

  • Pre-existing hemoptysis of a severity > grade 3 by NCI CTCAE criteria within 4 weeks prior to study entry
  • Uncontrolled hypertension
  • CHF, angina or arrhythmias
  • LVEF < 1 UNL
  • Existing a second malignancy within 5 years
  • Infected with HIV

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): NCT01850147


Contacts
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Contact: Junling Li 86-13801178891 drlijunling@yahoo.cn

Locations
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China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China, 100021
Sponsors and Collaborators
Chinese Academy of Medical Sciences
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Responsible Party: LI Junling, Professor and Chief physician, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01850147    
Other Study ID Numbers: SU-2013-041
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: May 9, 2013
Last Verified: May 2013
Keywords provided by LI Junling, Chinese Academy of Medical Sciences:
sunitinib
chemotherapy
non-small cell lung cancer
NSCLC
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action