Phase II Trial of Sunitinib (Sutent, SU11248) Maintenance Therapy After Induction Platinum-Based Chemotherapy in Patients With Extensive-Stage Small Cell Lung Cancer
Despite a high initial response rate, all patients with extensive-stage SCLC treated with
standard chemotherapy will develop disease progression, usually within one year of initial
treatment. Therefore, prolonging progression-free survival in this disease is meaningful for
clinical trials exploring agents such as sunitinib. Sunitinib is a drug that inhibits the
biological pathway responsible for the growth and spread of cancer cells. For this reason,
we believe that sunitinib maintenance therapy will delay or prevent recurrence and prolong
survival.
The goal of this study is to determine the progression-free survival rate in patients with
extensive-stage small cell lung cancer who had achieved complete response, partial response,
or stable disease with their previous platinum chemotherapy regimen, such as cisplatin or
carboplatin in combination with etoposide or irinotecan. In addition, the safety and
effectiveness of sunitinib will also be evaluated.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patients will be evaluated for response according to the international RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
All patients who have received at least one cycle of sunitinib will be considered evaluable for response to sunitinib
No
Gregory Kalemkerian, MD
Principal Investigator
University of Michigan Cancer Center
United States: Institutional Review Board
UMCC 2007.034
NCT00616109
September 2007
June 2015
Name | Location |
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University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |