Thalidomide and Tegafur/Uracil(UFUR) in the Treatment of Advanced Colorectal Cancer

Launched by NATIONAL CHENG-KUNG UNIVERSITY HOSPITAL · Apr 28, 2009

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically or cytologically confirmed colorectal carcinoma
• • Patients must have received at least one oxaliplatin-contained chemotherapy before the study and did not want to receive or tolerate irinotecan- contained chemotherapy
• • Presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as 20 mm with conventional CT or 10 mm with spiral CT scan
• • Age ≥ 18 year, ECOG performance status 0, 1, 2, 3
• • White blood cell (WBC) ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3 and hemoglobin ≥ 8 mg / dl
• • Serum creatinine level 2.0 mg/dL or lower
• • Serum bilirubin less than 1.5 times the upper limit of normal range (ULN)
• • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 2.5 times the ULN if no demonstrable liver metastases or less than 5 times the ULN in the presence of liver metastases
• • Require to wait 28 days before entry onto the study after being treated with any immunotherapy, or biologic systemic (including any target therapy)
• • Written informed consent to participate in the trial
• Exclusion Criteria:
• • Presence of CNS metastasis
• • Other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to the entry of study
• • Less than 4 weeks since previous treatment
• • Concomitant illness that might be aggregated by chemotherapy. For examples, active, non-controlled infection or other active, non-controlled disease such as congestive heart failure, angina pectoris, respiratory insufficiency, arrhythmia. It depends on investigation's decision.
• • Women of child-bearing potential without using a reliable and appropriate contraceptive method during study period
• • Pre existent sensory or motor neurotoxicity \> grade 2 according to National Cancer Institute (NCI) Common Toxicity Criteria (CTC) (disabling paresthesia and/or significant motor loss)
• • Patients who are receiving other concomitant chemotherapy, radiotherapy or any other investigational therapy