Status:
UNKNOWN
Thalidomide and Tegafur/Uracil(UFUR) in the Treatment of Advanced Colorectal Cancer
Lead Sponsor:
National Cheng-Kung University Hospital
Conditions:
Colon Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 chemothera...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00890188
Start Date
January 1 2009
End Date
June 1 2011
Last Update
May 7 2009
Active Locations (1)
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1
National Cheng-Kung University Hospital
Tainan, Taiwan, 704