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The Feasibility of Combing THALIDOMIDE and UFUR in the Treatment of Advanced Colorectal Cancer After Oxaliplatin-Contained Chemotherapy

Phase 2
18 Years
80 Years
Open (Enrolling)
Colon Cancer

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Trial Information

The Feasibility of Combing THALIDOMIDE and UFUR in the Treatment of Advanced Colorectal Cancer After Oxaliplatin-Contained Chemotherapy

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response(CR+PR) and Clinical benefit (CR+PR+SD)

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Peng Chan Lin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cheng-Kung University Hospital, Clinical Trial Center


Taiwan: Department of Health

Study ID:




Start Date:

January 2009

Completion Date:

June 2011

Related Keywords:

  • Colon Cancer
  • UFUR
  • Colorectal cancer
  • Oxaliplatin
  • Colonic Neoplasms
  • Colorectal Neoplasms