Effect of Colchicine for the Palliative Management of Hepatocellular Carcinoma

NCT01935700 | Completed Phase 2 Results

• 1 other identifier: 2013-04-03(I)
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Metastasis; Invasion

Keywords

hepatocellular carcinoma; colchicine

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  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.

  up to 72 months

Secondary Outcomes (1)

• Grade III Severe Adverse Events

  up to 72 months

Study Arms (1)

colchicine treated patients

EXPERIMENTAL

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

Interventions

Colchicine DRUG

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.

Also known as: Colicine, Tunfon and others, Drugbank Accession Number DB01394, PubChem CID 6167, CAS Registry Number: 64-86-8

colchicine treated patients

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Contrast-enhanced computed tomography or magnetic resonance imaging has evidence of distant metastasis or large vessel invasion caused by hepatocellular carcinoma.
• Patient has Child A hepatic reserved function

You may not qualify if:

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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

Related Publications (1)

• Lin ZY, Wu CC, Chuang YH, Chuang WL. Anti-cancer mechanisms of clinically acceptable colchicine concentrations on hepatocellular carcinoma. Life Sci. 2013 Sep 3;93(8):323-8. doi: 10.1016/j.lfs.2013.07.002. Epub 2013 Jul 16.

  PMID: 23871804 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasm Metastasis

Interventions

Colchicine; Colicins

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Zu-Yau Lin
• Organization: Kaohsiung Medical University Hospital

linzuyau@yahoo.com.tw

88677317123

Study Officials

• Zu Y Lin, MS

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: opeo labeled

Study Record Dates

• First Submitted: August 24, 2013
• First Posted: September 5, 2013
• Study Start: June 6, 2013
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: August 19, 2020
• Results First Posted: August 19, 2020

Record last verified: 2020-08

Locations

TW (1)