Sequential Use of Low-dose Sunitinib With Chemotherapy in Advanced NSCLC After Failure of Conventional Regimen
Conditions
Cancer - Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
sunitinib, chemotherapy, non-small cell lung cancer, NSCLC
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Sunitinib, chemotherapy
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
Status: Recruiting
Start Date
March 2013
Completion Date
December 2014
Sponsors
Chinese Academy of Medical Sciences
Source
Chinese Academy of Medical Sciences
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page