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

Primary Purpose

Colon Cancer

Status

Unknown status

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

THALIDOMIDE and UFUR

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring THALIDOMIDE, UFUR, Colorectal cancer, Oxaliplatin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Cheng-Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

THALIDOMIDE and UFUR

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To determine the progression free survival, overall survival (OS)and assess the safety profile

Full Information

NCT ID

NCT00890188

First Posted

April 22, 2009

Last Updated

May 5, 2009

Sponsor

National Cheng-Kung University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00890188

Brief Title

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

Acronym

UFUR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Unknown status

Study Start Date

January 2009 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Cheng-Kung University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer

Keywords

THALIDOMIDE, UFUR, Colorectal cancer, Oxaliplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

THALIDOMIDE and UFUR

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

THALIDOMIDE and UFUR

Intervention Description

T: Thalidomide (50): 150 mg/d ((1# tid) U: UFUR(100) 300 mg/d (1# tid) 28 days for one cycle

Primary Outcome Measure Information:

Title

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

To determine the progression free survival, overall survival (OS)and assess the safety profile

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peng Chan Lin, MD

Phone

+886-062353535

Ext

4559

pengchanlin@yahoo.com.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peng Chan Lin, MD

Organizational Affiliation

National Cheng-Kung University Hospital, Clinical Trial Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cheng-Kung University Hospital

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peng Chan Lin, MD

Phone

+886-06-2353535

Ext

4559

pengchanlin@yahoo.com.tw

First Name & Middle Initial & Last Name & Degree

Peng Chan Lin, MD

12. IPD Sharing Statement

Learn more about this trial

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

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