Trial Outcomes & Findings for LC Bead Embolization Agent With Doxorubicin in the Treatment Liver Metastasis From Melanoma (NCT NCT01010984)
NCT ID: NCT01010984
Last Updated: 2018-10-25
Results Overview
Adverse events were collected from all 20 subjects.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Date of surgery through 2 years post procedure or until patient death
Results posted on
2018-10-25
Participant Flow
Participant milestones
| Measure |
Tace Using LC Beads Loaded With 150mg of Doxorubicin
Tace using LC beads loaded with 150mg of Doxorubicin. May have up to 6 treatments.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LC Bead Embolization Agent With Doxorubicin in the Treatment Liver Metastasis From Melanoma
Baseline characteristics by cohort
| Measure |
Transcatheter Arterial Chemoembolization
n=20 Participants
TACE using LC beads loaded with Doxorubicin
LC beads loaded with Doxorubicin: During each TACE, 2 vials (1 vial, 75mg Doxorubicin) of 100-300 micrometer size LC beads loaded with doxorubicin will be delivered to the liver tumor(s). Total Doxorubicin dose for each TACE is 150mg
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Date of surgery through 2 years post procedure or until patient deathPopulation: Participants who received at least one dose of LC beads with doxorubin.
Adverse events were collected from all 20 subjects.
Outcome measures
| Measure |
Single Arm
n=20 Participants
Tace using LC beads loaded with 150mg of Doxorubicin. May have up to 6 treatments.
|
|---|---|
|
Incidence of Adverse Events
|
465 Events
|
SECONDARY outcome
Timeframe: Percentage of tumor response assessed up to 1 year post treatment.Population: Those who receive at least one dose of LC bead with doxorubin.
Progression is determined using Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Progressive disease is defined as at least 20% increase in the sum of the longest target lesions, taking as reference the smallest sum longest diameter recorded since start of treatment OR appearance of one or more new lesions greater then 1cm in size. Percentage of tumor response will be assessed up to 1 year post treatment.
Outcome measures
| Measure |
Single Arm
n=20 Participants
Tace using LC beads loaded with 150mg of Doxorubicin. May have up to 6 treatments.
|
|---|---|
|
Percentage of Tumor Response
|
2.46 percentage of tumor response
Interval 1.48 to 3.48
|
Adverse Events
Single Arm
Serious events: 19 serious events
Other events: 20 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Single Arm
n=20 participants at risk
Tace using LC beads loaded with 150mg of Doxorubicin. May have up to 6 treatments.
|
|---|---|
|
Hepatobiliary disorders
Hepatic Biliary Dilitation
|
15.0%
3/20 • Number of events 3
|
|
Gastrointestinal disorders
Intractable Nausea
|
15.0%
3/20 • Number of events 3
|
|
Gastrointestinal disorders
Cholecystitis
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal Enteritis
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
5.0%
1/20 • Number of events 1
|
|
Hepatobiliary disorders
Ruptured Hepatic Lesion
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Perforated Bowel
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
Urinary Tract Infection
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Stroke
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Staph Infection
|
5.0%
1/20 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Over Sedation
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Fever
|
5.0%
1/20 • Number of events 1
|
Other adverse events
| Measure |
Single Arm
n=20 participants at risk
Tace using LC beads loaded with 150mg of Doxorubicin. May have up to 6 treatments.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
70.0%
14/20 • Number of events 14
|
|
General disorders
Peripheral Edema
|
15.0%
3/20 • Number of events 3
|
|
Investigations
Weight Gain
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Weight Loss
|
15.0%
3/20 • Number of events 3
|
|
Investigations
Hyperbilirubinemia
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Hypertension
|
5.0%
1/20 • Number of events 1
|
|
Reproductive system and breast disorders
Penile Swelling
|
5.0%
1/20 • Number of events 1
|
|
Reproductive system and breast disorders
Vulvovaginal Burning Sensation
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
10.0%
2/20 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.0%
2/20 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Painful Respiration
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
2/20 • Number of events 2
|
|
Metabolism and nutrition disorders
Lack of Appetite
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
4/20 • Number of events 4
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
4/20 • Number of events 4
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.0%
1/20 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
1/20 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
10.0%
2/20 • Number of events 2
|
|
Cardiac disorders
Bradycardia
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Confusional State
|
10.0%
2/20 • Number of events 2
|
|
Psychiatric disorders
Hallucinations
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Depression
|
10.0%
2/20 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
15.0%
3/20 • Number of events 3
|
|
Psychiatric disorders
Somnolence
|
15.0%
3/20 • Number of events 3
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
1/20 • Number of events 1
|
|
Immune system disorders
Sinus Congestion
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Fatigue
|
30.0%
6/20 • Number of events 6
|
|
General disorders
Non-Cardiac Chest Pain
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Pain
|
5.0%
1/20 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
5.0%
1/20 • Number of events 1
|
|
Hepatobiliary disorders
Bile Duct Necrosis
|
10.0%
2/20 • Number of events 2
|
|
Hepatobiliary disorders
Ocular Icterus
|
5.0%
1/20 • Number of events 1
|
|
Hepatobiliary disorders
Biliary Dilitation with Biloma
|
5.0%
1/20 • Number of events 1
|
|
Hepatobiliary disorders
Biliary Dilatation
|
5.0%
1/20 • Number of events 1
|
|
Hepatobiliary disorders
Biloma
|
5.0%
1/20 • Number of events 1
|
|
Eye disorders
Cataract
|
5.0%
1/20 • Number of events 1
|
|
Eye disorders
Vision Blurred
|
5.0%
1/20 • Number of events 1
|
|
Eye disorders
Diplopia
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain Chest
|
10.0%
2/20 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
10.0%
2/20 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
15.0%
3/20 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Blood Pressure Increased
|
10.0%
2/20 • Number of events 2
|
|
Investigations
Blood Bilirubin Increased
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Sepsis
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Staphylococcal Infection
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
2/20 • Number of events 2
|
|
Infections and infestations
Fungal Skin Infection
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
Chromaturia
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
Urinary Retention
|
10.0%
2/20 • Number of events 2
|
|
Vascular disorders
Hypertension
|
15.0%
3/20 • Number of events 3
|
|
Vascular disorders
Thrombophlebitis
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Orthostatic Hypotension
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Hypotension
|
10.0%
2/20 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
20.0%
4/20 • Number of events 4
|
|
Nervous system disorders
Lethargy
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Number of events 2
|
|
Nervous system disorders
Headache
|
20.0%
4/20 • Number of events 4
|
|
Nervous system disorders
Tremor
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
20.0%
4/20 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalized
|
10.0%
2/20 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place