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Effect of Colchicine for the Palliative Management of Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01935700
Recruitment Status : Completed
First Posted : September 5, 2013
Results First Posted : August 19, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Zu-Yau Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Description
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Brief Summary:
This trial is to evaluate the potential of colchicine for the palliative management of hepatocellular carcinoma patients with distant metastasis or large vessel invasion using the Department of Health R.O.C. approved doses and methods of administration.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Metastasis Invasion Drug: Colchicine Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: opeo labeled
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation the Potential of Colchicine for the Palliative Management of Hepatocellular Carcinoma Patients With Distant Metastasis or Large Vessel Invasion
Actual Study Start Date : June 6, 2013
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care
Drug Information available for: Colchicine

Arms and Interventions
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Arm Intervention/treatment
Experimental: colchicine treated patients
2 tablets (0.5 mg/tablet) of colchicine three times per day (after breakfast, lunch and dinner); continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial
 Drug: Colchicine

Adjustment the dosage of colchicine during study:

The colchicine dosage will be changed when the hepatic reserved function of the participant changes from Child A to B according as following: 2 tablets after breakfast, 1 tablet after lunch and 2 tablets after dinner; continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial. If the hepatic reserved function of the participant changes to Child C, colchicine will be stopped and participant receives regular follow-up only.If participant suffers from severe diarrhea, colchicine will be temporarily stopped. When the symptom of diarrhea subsides, colchicine will be given again but the dose will be reduced 0.5 mg/day.

Other Name: Colicine, Tunfon and others, Drugbank Accession Number DB01394, PubChem CID 6167, CAS Registry Number: 64-86-8


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: up to 72 months ]
    The overall survival of the participants calculated from the date of enrollment to the date of death will be compared with the control group with the same TNM and the Barcelona Clinic Liver Cancer (BCLC) staging collected from 2005/1/1 to the end of this study. The overall survival of the control group was calculated from the date of receiving sorafenib treatment to the date of death.


Secondary Outcome Measures :
  1. Grade III Severe Adverse Events [ Time Frame: up to 72 months ]
    The type and frequency of grade III severe adverse events based on the Common Terminology Criteria for Adverse Events (CTCAE) noted during the study period.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. . Patient has at least one of the following criteria: (1) positive for hepatocellular carcinoma evidenced by cytology or pathology, (2) serum alpha-fetoprotein level > 400 ng/mL and has evidence of hepatocellular carcinoma provided by contrast-enhanced computed tomography or magnetic resonance imaging.
  2. . Contrast-enhanced computed tomography or magnetic resonance imaging has evidence of distant metastasis or large vessel invasion caused by hepatocellular carcinoma.
  3. . Patient has Child A hepatic reserved function

Exclusion Criteria:

  1. . There are life-threatening hemorrhage including gastrointestinal hemorrhage and hemorrhage from other vital organs such as lungs or brain.
  2. . There are life-threatening bacterial, fungal or viral infection (not included hepatitis B and C virus).
  3. . Patient has serum creatinine level > 1.5 mg/dL.
  4. . Patient must receive long-term medication of statin or fibrates drugs and these medications can not be changed.
  5. . Patient has white blood cell count < 1500/µL, platelet count < 30000/µL or hemoglobin < 9.0 gm/dL after medication.
  6. . Pregnant woman or plan to be a pregnant woman
  7. . allergy to colchicine or has history of severe side effects caused by colchicine
  8. . Patient has received systemic chemotherapy within 2 months before enrollment or plans to receive systemic chemotherapy in the future.
  9. . Patient is under or plans to receive Nexavar or other clinical trial testing drug.
  10. . Patient has severe malfunction of vital organs and can not participate in this study justified by the doctor in this research team.
  11. . Patient is under or plans to receive Chinese traditional medicine or herb drugs.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935700


Locations
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Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Principal Investigator: Zu Y Lin, MS Kaohsiung Medical University
  Study Documents (Full-Text)

Documents provided by Zu-Yau Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] June 6, 2013

More Information
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Publications:

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Responsible Party: Zu-Yau Lin, professor, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01935700    
Other Study ID Numbers: 2013-04-03(I)
First Posted: September 5, 2013    Key Record Dates
Results First Posted: August 19, 2020
Last Update Posted: August 19, 2020
Last Verified: August 2020
Keywords provided by Zu-Yau Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital:
hepatocellular carcinoma
colchicine
Additional relevant MeSH terms:
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Carcinoma
Neoplasm Metastasis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Liver Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents