Thalidomide and Tegafur/Uracil(UFUR) in the Treatment of Advanced Colorectal Cancer
Status:
Unknown status
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
Colorectal cancer is a major health problem in Western society contributing to a high
mortality rate. Treatment options for the majority of patients with metastases are limited to
cytotoxic chemotherapies. The first line chemotherapy containing with oxaliplatin is
recommend by guideline. The use of antiangiogenic agents, either alone or in combination with
other therapies may provide an alternative treatment modality in the management of these
patients. Metronomic chemotherapy refers to the close, regular administration of a
chemotherapeutic drug, over prolonged periods. The advantages of metronomic chemotherapy
include reducing acute toxicities and sometimes surprisingly good activity against drug
resistant tumors via antiangiogenic effect.
Thalidomide is an agent, which has shown potential in the treatment of hematological and
solid tissue malignancies such as multiple myeloma via antiangiogenic mechanism.
Tegafur/uracil (UFUR) is one of the effective chemotherapeutics reported to be an effective
antiangiogenic agent in an animal model of metastatic colorectal cancers (CRCs).
In the present study, the investigators will try to use low dose metronomic schedule of
thalidomide with tegafur/uracil regimen to see the anti tumor efficacy in recurrent and
metastasis colorectal cancer patients after oxaliplatin-contained chemotherapy.
The primary endpoints are overall response rate and clinical benefit and the secondary
endpoint were to determine the progression free survival, and duration of objective response,
the overall survival (OS) and to assess the safety profile. This is a prospective phase II
study. After having checked all eligibility criteria, patients will be treated with
Tegafur/Uracil (TU) regimen. About 34 patients will be enrolled.