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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by National Cheng-Kung University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT00890188
First received: April 22, 2009
Last updated: May 5, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Colon Cancer
Drug: THALIDOMIDE and UFUR
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Feasibility of Combing THALIDOMIDE and UFUR in the Treatment of Advanced Colorectal Cancer After Oxaliplatin-Contained Chemotherapy

Resource links provided by NLM:


Further study details as provided by National Cheng-Kung University Hospital:

Primary Outcome Measures:
  • Overall response(CR+PR) and Clinical benefit (CR+PR+SD) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the progression free survival, overall survival (OS)and assess the safety profile [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 34
Study Start Date: January 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: THALIDOMIDE and UFUR 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890188

Contacts
Contact: Peng Chan Lin, MD +886-062353535 ext 4559 pengchanlin@yahoo.com.tw

Locations
Taiwan
National Cheng-Kung University Hospital Recruiting
Tainan, Taiwan, 704
Contact: Peng Chan Lin, MD    +886-06-2353535 ext 4559    pengchanlin@yahoo.com.tw   
Principal Investigator: Peng Chan Lin, MD         
Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
Principal Investigator: Peng Chan Lin, MD National Cheng-Kung University Hospital, Clinical Trial Center
  More Information

No publications provided

Responsible Party: Peng-Chan Lin/Doctor, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT00890188     History of Changes
Other Study ID Numbers: HR-97-035
Study First Received: April 22, 2009
Last Updated: May 5, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by National Cheng-Kung University Hospital:
THALIDOMIDE
UFUR
Colorectal cancer
Oxaliplatin

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Thalidomide
Oxaliplatin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 15, 2014