Salvage Therapy With Sunitinib,Docetaxel and Platinum on Metastatic or Unresectable Non Small Cell Lung Cancer
Status:
Unknown status
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
Sunitinib shows anti-tumor activity in a variety of human non-small cell lung tumor ex vivo
models. Many Phases II and III clinical trials of sunitinib in several solid tumors are
completed or still ongoing. So far, the efficacy of sunitinb has been confirmed by the phase
III trial for imatinib-resistance or intolerance advanced gastrointestinal stromal tumor
patients. And sutent was approved to effective by two phase II trials in advanced renal cell
carcinoma patients after failure of immunotherapies, and one phase III trial in
treatment-naive advanced renal carcinoma patients. Sunitinib (SUTENT ®) has been approved by
U.S. Food and Drug Administration (FDA) for the treatment of advanced renal carcinoma
patients and in gastrointestinal stromal tumor patients who are intolerant or progressed
after imatinib mesylate. European Medicines Agency (EMEA) conditionally granted the marketing
approval for the treatment of metastatic renal carcinoma patients after failure of
immunotherapy.
A phase II trial (A6181040 study) on non-small cell lung cancer patients treated with
sunitinib alone showed anti-tumor activity. In 63 enrolled patients treated with 4/2 schedule
(4 weeks treatment, then two weeks interruption), 7 patients are confirmed partial response
(overall response rate, 11%), and median progress-free time is 14.3 weeks. Presently, a phase
III study is underway on non-small cell lung cancer patients followed by and now is under
recruiting.
Non-small cell lung cancer cells often over-express vascular endothelial growth factor (VEGF)
receptors. Besides, the expression of the VEGF ligands is also correlated with increased
tumor angiogenesis, as well as shortened survival time. One study treated with VEGF-directed
monoclonal antibody (bevacizumab) and VEGFR and platelet-derived growth factor receptor
(PDGFR) small molecule inhibitors (sunitinib) showed that some non-small cell lung cancer
patients are with anti-tumor activity.
The chemotherapy drugs, such as docetaxel and platinum-based compounds, were with evidence
that they have direct cytotoxicity to cancer cells. Therefore, the investigators are paying
attention to the efficacy of combining sunitinib and conventional chemotherapy in this study.
The study is designed as first line of salvage therapy on metastatic or unresectable
non-small cell lung cancer patients. The main goals of this study is to evaluate the overall
response rate (ORR) and duration of response (DR) of sunitinib in combinational with
docetaxel and cisplatin in chemotherapy-naive advanced or metastatic non-small cell lung
cancer patients.