A Phase II Protocol of Arsenic Trioxide (Trisenox) in Subjects With Advanced Primary Carcinoma of the Liver

NCT00582400 | Terminated Phase 2 Results

• 2 other identifiers: 04-267PI-Initiated
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is: evaluate the safety and activity of administering arsenic trioxide (Trisenox) in the treatment of unresectable or metastatic primary liver cancer, to evaluate the qualitative and quantitative toxicities of this treatment, and to measure the response to treatment and the patterns of failure and survival. The primary response measurements will be the achievement of an objective tumor response, response duration and progression-free survival

Conditions

Carcinoma, Hepatocellular

Keywords

livers, hepatocellular carcinoma (HCC)

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment Related Toxicity.

  6 years

• Number of Patients With Response to Treatment (RECIST Criteria)

  Response included complete response, partial response or stable disease.

  6 years

Secondary Outcomes (2)

• Duration of Response.

  6 years

• Progression Free Survival

  6 years

Study Arms (1)

I

EXPERIMENTAL

Drug: arsenic trioxide

Interventions

arsenic trioxide DRUG

Trisenox will be diluted with 100 to 250 mL 0.9% Sodium Chloride injection, USP, using proper aseptic technique, immediately after withdrawal from the ampule. The Trisenox ampule is single-use and does not contain any preservatives. Unused portions of each ampule should be discarded properly. Trisenox is not to be mixed with other medications. The loading dose of Trisenox will be administered intravenously over 2 hours. The infusion duration may be extended up to 4 hours if acute vasomotor reactions are observed. The drug will be administered IV through a functional peripheral or central venous line. Trisenox is not a vesicant, and may be a mild irritant if administered into the skin without dilution.

Also known as: Trisenox

I

Eligibility Criteria

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

You may qualify if:

• Signed Informed Consent
• ECOG/Zubrod/SWOG Performance Status \< 2
• Life expectancy \> 12 weeks
• Male or female' age \>18 years Subjects of childbearing potential must be using an effective means of contraception.
• Histologic diagnosis of HCC or cholangiocarcinoma that is locally advanced but cannot be treated adequately by radiotherapy or surgery (more than one lesion, portal vein involvement, or poor hepatic reserve); or metastatic disease or an AFB \> 20 w/CT scan consistent with HCC
• Renal function: Serum creatinine \< 2.0 mg/dl
• Serum calcium \< 12 mg/dl
• Serum electrolytes, including magnesium and potassium, within normal limits

You may not qualify if:

• Pregnant or lactating females
• Myocardial infarction or ischemia within the 6 months before Cycle 0' Day 0
• Uncontrolled' clinically significant dysrhythmia
• Known left ventricular Ejection Fraction below the normal limit for UTMB
• History of prior malignancy within the prior five years, with the exception of non-melanoma carcinomas of the skin, and carcinoma in situ of the cervix
• More than one prior chemotherapy regimens for liver cancer (subjects who are receiving antineoplastic agents for non-malignant conditions, such as methotrexate for rheumatoid arthritis, must be off such therapy for at least four weeks prior to receiving the first dose of protocol therapy, and may not receive such therapy while participating in this protocol)
• Receiving any other chemotherapy or cytokine therapy
• Subjects receiving radiation therapy (Trisenox will be held during the administration of palliative or emergent radiotherapy)
• Subjects who have received radiofrequency ablation or hepatic arterial embolization within the past four weeks (patients who have received prior RFA or HAE are otherwise eligible)
• Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion
• Uncontrolled metastatic disease of the central nervous system
• Prior and on-going Grade 2-4 peripheral neuropathy, as measured by NCI Common Toxicity Criteria version 3.0
• Radiotherapy within the 2 weeks before Cycle 1' Day 1
• Surgery within the 2 weeks before Cycle 1' Day 1
• Any co morbid condition that' in the view of the attending physician' renders the subject at high risk from treatment complications

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Arsenic Trioxide

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

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Dr. Avi B. Markowitz
• Organization: University of Texas Medical Branch at Galveston

abmarkow@utmb.edu

4097721164

Study Officials

• Avi B. Markowitz, MD

  The University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• 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: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: September 1, 2004
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 19, 2016
• Results First Posted: February 19, 2016

Record last verified: 2010-01

Locations

US (1)