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

• Status: Terminated
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Treatments: Arsenic Trioxide

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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