Phase II Study of Salvage Therapy With Sunitinib,Docetaxel and Platinum on Metastatic or Unresectable Non Small Cell Lung Cancer
Study Design This is a single-center, open-label, phase II clinical trial. Simon two-stage
analysis is adopted.The sample size in the first stage is 16 patients. The length of study
is approximately 24 months. The targeted subject is patient with metastatic or unresectable
non-small cell lung cancer.
Study Endpoints Primary Endpoint Assess the response rate of sunitinib, docetaxel and
cisplatin in the treatment of naïve chemotherapy metastatic or unresectable non-small cell
lung cancer patients.
1. Time to disease progression (defined as the time period from the start of investigated
medication to investigator assessed disease progression) at the end of study.
2. Duration of survival (defined as the time period from the start of investigated
medication to death).
3. Safety profile of sunitinib in combination with docetaxel and cisplatin: cardiac
toxicity assessed in accordance with National Cancer Institute Common Toxicity Criteria
(version 3.0). The incidence of serious adverse events related to the treatment and the
incidence of specific adverse events (serious and non-serious) such as
gastro-intestinal perforation, wound healing complication, bleeding, hypertension,
arterial thromboembolic events and proteinuria will be investigated. NCI-CTCAE criteria
(version 3.0) will be used.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
response rate by RECIST criteria
every 3 months
Cheng-Jeng Tai, M.D.
Section of Hematology-Oncology, Department of Medicine, Taipei Medical University Hospital
Taiwan: Institutional Review Board