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

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ClinicalTrials.gov Identifier: NCT00890188
Recruitment Status : Unknown
Verified May 2009 by National Cheng-Kung University Hospital.
Recruitment status was:  Recruiting
First Posted : April 29, 2009
Last Update Posted : May 7, 2009
Sponsor:
Information provided by:
National Cheng-Kung University Hospital

Tracking Information
First Submitted Date  ICMJE April 22, 2009
First Posted Date  ICMJE April 29, 2009
Last Update Posted Date May 7, 2009
Study Start Date  ICMJE January 2009
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2009)
Overall response(CR+PR) and Clinical benefit (CR+PR+SD) [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2009)
  • Overall response rate (CR+PR) [ Time Frame: 3 months ]
  • Clinical benefit (CR+PR+SD) [ Time Frame: 3 months ]
Change History Complete list of historical versions of study NCT00890188 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2009)
To determine the progression free survival, overall survival (OS)and assess the safety profile [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2009)
  • To determine the progression free survival, and duration of objective response [ Time Frame: 3 months ]
  • To evaluate the overall survival (OS) [ Time Frame: 3 months ]
  • To assess the safety profile [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thalidomide and Tegafur/Uracil(UFUR) in the Treatment of Advanced Colorectal Cancer
Official Title  ICMJE The Feasibility of Combing THALIDOMIDE and UFUR in the Treatment of Advanced Colorectal Cancer After Oxaliplatin-Contained Chemotherapy
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 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colon Cancer
Intervention  ICMJE Drug: THALIDOMIDE and UFUR
T: Thalidomide (50): 150 mg/d ((1# tid) U: UFUR(100) 300 mg/d (1# tid) 28 days for one cycle
Study Arms  ICMJE Experimental: THALIDOMIDE and UFUR
Intervention: Drug: THALIDOMIDE and UFUR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 28, 2009)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2011
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00890188
Other Study ID Numbers  ICMJE HR-97-035
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peng-Chan Lin/Doctor, National Cheng-Kung University Hospital
Study Sponsor  ICMJE National Cheng-Kung University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peng Chan Lin, MD National Cheng-Kung University Hospital, Clinical Trial Center
PRS Account National Cheng-Kung University Hospital
Verification Date May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP