Colon CancerPhase 2UFURNCT00890188
Thalidomide and Tegafur/Uracil(UFUR) in the Treatment of Advanced Colorectal Cancer
A Phase 2 study testing THALIDOMIDE and UFUR in people with Colon Cancer, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- THALIDOMIDE and UFUR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2009to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University Hospital
Tainan, 704
Peng Chan Lin, MD, +886-06-2353535 ext. 4559, pengchanlin@yahoo.com.tw
Peng Chan Lin, MD
About this study
Official title: The Feasibility of Combing THALIDOMIDE and UFUR in the Treatment of Advanced Colorectal Cancer After Oxaliplatin-Contained Chemotherapy
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).
Read more
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.
- Conditions
- Colon Cancer
- Being tested
- THALIDOMIDE and UFUR
- Keywords
- THALIDOMIDE, UFUR, Colorectal cancer, Oxaliplatin
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THALIDOMIDE and UFURDrug
T: Thalidomide (50): 150 mg/d ((1# tid) U: UFUR(100) 300 mg/d (1# tid) 28 days for one cycle
| Study group | Role | What they receive |
|---|---|---|
| THALIDOMIDE and UFUR | Experimental | Not described Receives: Drug: THALIDOMIDE and UFUR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response(CR+PR) and Clinical benefit (CR+PR+SD)
Measured: 3 months
Secondary outcomes (1)
To determine the progression free survival, overall survival (OS)and assess the safety profile
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2010 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Peng Chan Lin, MD, Principal investigator, National Cheng-Kung University Hospital, Clinical Trial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890188
- Sponsor's protocol ID
- HR-97-035
- Acronym
- UFUR
- Status last verified
- May 2009
- First submitted
- 22 Apr 2009
- Last updated
- 7 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Combing THALIDOMIDE and UFUR in the Treatment of Advanced Colorectal Cancer After Oxaliplatin-Contained Chemotherapy
- ClinicalTrials.gov ID
- NCT00890188
- Acronym / sponsor ID
- UFUR / HR-97-035
- Conditions
- Colon Cancer
- Keywords
- THALIDOMIDE, UFUR, Colorectal cancer, Oxaliplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 29 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| THALIDOMIDE and UFUR | Experimental | Drug: THALIDOMIDE and UFUR |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THALIDOMIDE and UFURT: Thalidomide (50): 150 mg/d ((1# tid) U: UFUR(100) 300 mg/d (1# tid) 28 days for one cycle | Drug | THALIDOMIDE and UFUR |
Primary outcome
Overall response(CR+PR) and Clinical benefit (CR+PR+SD)
Time frame: 3 months
1 secondary outcome
To determine the progression free survival, overall survival (OS)and assess the safety profile
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peng Chan Lin, MD principal investigator
National Cheng-Kung University Hospital, Clinical Trial Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing THALIDOMIDE and UFUR in people with Colon Cancer, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peng Chan Lin, MD (+886-062353535 ext. 4559, pengchanlin@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response(CR+PR) and Clinical benefit (CR+PR+SD) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2009; AzTrials last refreshed its copy on 8 Nov 2026.