NCT01019798

Salvage Therapy With Sunitinib,Docetaxel and Platinum on Metastatic or Unresectable Non Small Cell Lung Cancer

Phase II Study of Salvage Therapy With Sunitinib,Docetaxel and Platinum on Metastatic or Unresectable Non Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Taipei Medical University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Secondary Endpoint 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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	sunitinib, docetaxel, cisplatin	1. Sunitinib given 10 days within 14 days of each cycle。 2. Sunitinib 25 mg/day with adjust dosage according to patient's condition, but should return to 25 mg when feasible or should withdraw from this study. 3. Docetaxel 40-50 mg/m2, cisplatin 50 mg/m2 every 2 weeks. 4. Overall 12 cycles (24 weeks)

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-12-01
• Completion: 2011-12-01
• First posted: 2009-11-25
• Last updated: 2009-11-25

Locations

1 site across 1 country: Taiwan