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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01850147
• Other study ID #: SU-2013-041
• Status: Recruiting
• Phase: Phase 2
• First received: April 18, 2013
• Last updated: May 7, 2013
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2013
• Source: Chinese Academy of Medical Sciences
• Contact: Junling Li
• Phone: 86-13801178891
• Email: drlijunling[@]yahoo.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival	The primary objective of this study is to evaluate the median progression-free survival of this sequential regimen.	up to 2 years	No
Secondary	overall survival	To evaluate the median over-all survival of this regimen	up to 2 years	No
Secondary	disease control rate	To evaluate the disease-control rate of this regimen.	up to 6 months	No
Secondary	Safety	To evaluate the safety of this regimen including the rate and grade of adverse effects.	up to 2 years	Yes