Status:
UNKNOWN
Sequential Use of Low-dose Sunitinib With Chemotherapy in Advanced NSCLC After Failure of Conventional Regimen
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Cancer
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01850147
Start Date
March 1 2013
End Date
December 1 2014
Last Update
May 9 2013
Active Locations (1)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021