Trial Outcomes & Findings for A Phase II Protocol of Arsenic Trioxide (Trisenox) in Subjects With Advanced Primary Carcinoma of the Liver (NCT NCT00582400)

NCT ID: NCT00582400

Last Updated: 2016-02-19

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 9 participants
• Primary outcome timeframe: 6 years
• Results posted on: 2016-02-19

Participant Flow

Nine patients were enrolled from 10/13/04 to 09/05/07 from the outpatient clinics (both free-world and prisoners). The median age of patients was 57 years (range 50-62) and included 8 males and 1 female.

No patients had previous systemic therapy.

Participant milestones

Measure	Arsenic Trioxide Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
Overall Study STARTED	9
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arsenic Trioxide n=9 Participants Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 years

Outcome measures

Measure	Arsenic Trioxide n=9 Participants Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
Number of Participants With Treatment Related Toxicity.	0 participants

PRIMARY outcome

Timeframe: 6 years

Population: Participants who were evaluable for response

Response included complete response, partial response or stable disease.

Outcome measures

Measure	Arsenic Trioxide n=7 Participants Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
Number of Patients With Response to Treatment (RECIST Criteria)	1 participants

SECONDARY outcome

Timeframe: 6 years

Population: Participants with response

Time to progression.

Outcome measures

Measure	Arsenic Trioxide n=1 Participants Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
Duration of Response.	8 months Interval 8.0 to 8.0

SECONDARY outcome

Timeframe: 6 years

Population: 1 evaluable participant lost to follow up. No data collected.

Time to progression from start of treatment

Outcome measures

Outcome data not reported

Adverse Events

Arsenic Trioxide (Trisenox)

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arsenic Trioxide (Trisenox) n=9 participants at risk arsenic trioxide: 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.
Gastrointestinal disorders hemorrhagic diarrhea	11.1% 1/9 • Number of events 1
Gastrointestinal disorders abdominal pain	11.1% 1/9
Musculoskeletal and connective tissue disorders bilateral extremity edema	11.1% 1/9 • Number of events 1

Other adverse events

Measure	Arsenic Trioxide (Trisenox) n=9 participants at risk arsenic trioxide: 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.
Gastrointestinal disorders abdominal pain	11.1% 1/9 • Number of events 1
Gastrointestinal disorders abdominal edema	11.1% 1/9 • Number of events 1
Musculoskeletal and connective tissue disorders bilateral lower extremity weakness	11.1% 1/9 • Number of events 1
Respiratory, thoracic and mediastinal disorders dyspnea	11.1% 1/9 • Number of events 1

Additional Information

Dr. Avi B. Markowitz

University of Texas Medical Branch at Galveston

Phone: 4097721164

Email: abmarkow@utmb.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place