Trial Outcomes & Findings for Sunitinib and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery (NCT NCT00524316)
NCT ID: NCT00524316
Last Updated: 2017-05-09
Results Overview
median progression free survival in months
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Results posted on
2017-05-09
Participant Flow
Participant milestones
| Measure |
Treatment: Sunitinib and Chemoembolization
Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Treatment: Sunitinib and Chemoembolization
Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Disease Progression
|
7
|
Baseline Characteristics
Sunitinib and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Treatment: Sunitinib and Chemoembolization
n=16 Participants
Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsPopulation: All treated and eligible patients.
median progression free survival in months
Outcome measures
| Measure |
Treatment: Sunitinib and Chemoembolization
n=16 Participants
Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
|
|---|---|
|
Progression-free Survival
|
8.0 months
Interval 4.3 to 9.3
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsPopulation: All treated and eligible patients
median survival in months
Outcome measures
| Measure |
Treatment: Sunitinib and Chemoembolization
n=16 Participants
Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
|
|---|---|
|
Overall Survival
|
15.1 months
Interval 6.3 to 24.5
|
SECONDARY outcome
Timeframe: Baseline, day 8, day 10, day 28 and day 35Population: Due to the study's early termination and inadequate number of patients, no data were collected for this Outcome Measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Daily while on treatment through study completion, an average of 1 yearPopulation: All treated and eligible patients
Number of participants with adverse advent. Please refer to adverse event reporting for more detail.
Outcome measures
| Measure |
Treatment: Sunitinib and Chemoembolization
n=16 Participants
Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
|
|---|---|
|
Safety and Tolerability
|
16 participants
|
SECONDARY outcome
Timeframe: Baseline and Cycle 2Population: All treated and eligible patients
We utilized the FACT-HEP TOTAL SCORE (version 4) quality-of-life scale, which is a 45 item scale ranging from 96-178. Higher scores reflect better quality of life. No subscales were analyzed.
Outcome measures
| Measure |
Treatment: Sunitinib and Chemoembolization
n=16 Participants
Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
|
|---|---|
|
Assess the Change in the Quality of Life Among Patients Using the FACTHep (Version 4) for Hepatobiliary Cancers.
Baseline
|
143.6 units on a scale
Standard Deviation 25.1
|
|
Assess the Change in the Quality of Life Among Patients Using the FACTHep (Version 4) for Hepatobiliary Cancers.
Cycle 2
|
136.8 units on a scale
Standard Deviation 21.9
|
SECONDARY outcome
Timeframe: Baseline, week 7 and every 6 weeks afterPopulation: All treated and eligible patients
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment: Sunitinib and Chemoembolization
n=16 Participants
Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
|
|---|---|
|
Tumor Marker Response (AFP)
|
13 percentage of participants
Interval 2.0 to 38.0
|
Adverse Events
Treatment: Sunitinib and Chemoembolization
Serious events: 16 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment: Sunitinib and Chemoembolization
n=16 participants at risk
Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
2/16 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
2/16 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 3
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
12.5%
2/16 • Number of events 2
|
|
Gastrointestinal disorders
Pancreatitis
|
6.2%
1/16 • Number of events 3
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Pyrexia
|
6.2%
1/16 • Number of events 3
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Lipase increased
|
6.2%
1/16 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
2/16 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.2%
1/16 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
1/16 • Number of events 3
|
|
Psychiatric disorders
Confusional state
|
6.2%
1/16 • Number of events 3
|
|
Renal and urinary disorders
Renal failure
|
6.2%
1/16 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
1/16 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.2%
1/16 • Number of events 3
|
Other adverse events
| Measure |
Treatment: Sunitinib and Chemoembolization
n=16 participants at risk
Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
68.8%
11/16 • Number of events 70
|
|
Blood and lymphatic system disorders
Leukopenia
|
62.5%
10/16 • Number of events 82
|
|
Blood and lymphatic system disorders
Lymphopenia
|
68.8%
11/16 • Number of events 127
|
|
Blood and lymphatic system disorders
Neutropenia
|
43.8%
7/16 • Number of events 35
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
81.2%
13/16 • Number of events 92
|
|
Cardiac disorders
Arrhythmia
|
6.2%
1/16 • Number of events 3
|
|
Cardiac disorders
Tachycardia
|
6.2%
1/16 • Number of events 1
|
|
Endocrine disorders
Hyperthyroidism
|
12.5%
2/16 • Number of events 2
|
|
Endocrine disorders
Hypothyroidism
|
12.5%
2/16 • Number of events 10
|
|
Eye disorders
Retinal haemorrhage
|
6.2%
1/16 • Number of events 1
|
|
Eye disorders
Vision blurred
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
1/16 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal distension
|
18.8%
3/16 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain
|
81.2%
13/16 • Number of events 54
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Cheilitis
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
6.2%
1/16 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
62.5%
10/16 • Number of events 34
|
|
Gastrointestinal disorders
Diarrhoea
|
62.5%
10/16 • Number of events 41
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
2/16 • Number of events 4
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
2/16 • Number of events 5
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
2/16 • Number of events 4
|
|
Gastrointestinal disorders
Eructation
|
6.2%
1/16 • Number of events 3
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • Number of events 3
|
|
Gastrointestinal disorders
Gastritis
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
12.5%
2/16 • Number of events 5
|
|
Gastrointestinal disorders
Gingival pain
|
6.2%
1/16 • Number of events 3
|
|
Gastrointestinal disorders
Glossodynia
|
12.5%
2/16 • Number of events 4
|
|
Gastrointestinal disorders
Lip dry
|
6.2%
1/16 • Number of events 3
|
|
Gastrointestinal disorders
Melaena
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
68.8%
11/16 • Number of events 51
|
|
Gastrointestinal disorders
Oral pain
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
12.5%
2/16 • Number of events 6
|
|
Gastrointestinal disorders
Stomatitis
|
31.2%
5/16 • Number of events 16
|
|
Gastrointestinal disorders
Toothache
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
62.5%
10/16 • Number of events 42
|
|
General disorders
Chills
|
31.2%
5/16 • Number of events 13
|
|
General disorders
Cyst
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Fatigue
|
93.8%
15/16 • Number of events 69
|
|
General disorders
Gait disturbance
|
12.5%
2/16 • Number of events 4
|
|
General disorders
Influenza like illness
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
18.8%
3/16 • Number of events 5
|
|
General disorders
Oedema peripheral
|
18.8%
3/16 • Number of events 3
|
|
General disorders
Pyrexia
|
43.8%
7/16 • Number of events 23
|
|
Hepatobiliary disorders
Cholangitis
|
6.2%
1/16 • Number of events 3
|
|
Hepatobiliary disorders
Cholecystitis
|
6.2%
1/16 • Number of events 3
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
50.0%
8/16 • Number of events 54
|
|
Infections and infestations
Fungal infection
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Gingival infection
|
6.2%
1/16 • Number of events 6
|
|
Infections and infestations
Infection
|
12.5%
2/16 • Number of events 2
|
|
Infections and infestations
Oral candidiasis
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Subcutaneous abscess
|
6.2%
1/16 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
6.2%
1/16 • Number of events 4
|
|
Investigations
Alanine aminotransferase increased
|
56.2%
9/16 • Number of events 44
|
|
Investigations
Ammonia increased
|
6.2%
1/16 • Number of events 4
|
|
Investigations
Aspartate aminotransferase increased
|
87.5%
14/16 • Number of events 107
|
|
Investigations
Blood alkaline phosphatase increased
|
68.8%
11/16 • Number of events 46
|
|
Investigations
Blood amylase increased
|
25.0%
4/16 • Number of events 25
|
|
Investigations
Blood bicarbonate decreased
|
6.2%
1/16 • Number of events 3
|
|
Investigations
Blood bilirubin increased
|
12.5%
2/16 • Number of events 9
|
|
Investigations
Blood creatinine increased
|
25.0%
4/16 • Number of events 17
|
|
Investigations
Blood fibrinogen decreased
|
6.2%
1/16 • Number of events 1
|
|
Investigations
International normalised ratio increased
|
12.5%
2/16 • Number of events 6
|
|
Investigations
Lipase increased
|
31.2%
5/16 • Number of events 24
|
|
Investigations
Weight decreased
|
50.0%
8/16 • Number of events 20
|
|
Metabolism and nutrition disorders
Anorexia
|
81.2%
13/16 • Number of events 56
|
|
Metabolism and nutrition disorders
Dehydration
|
43.8%
7/16 • Number of events 21
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
31.2%
5/16 • Number of events 16
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
31.2%
5/16 • Number of events 28
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
12.5%
2/16 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
68.8%
11/16 • Number of events 73
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
18.8%
3/16 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
18.8%
3/16 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
2/16 • Number of events 8
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
87.5%
14/16 • Number of events 71
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
2/16 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.8%
3/16 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.2%
1/16 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
37.5%
6/16 • Number of events 27
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
2/16 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.8%
3/16 • Number of events 5
|
|
Nervous system disorders
Balance disorder
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
31.2%
5/16 • Number of events 15
|
|
Nervous system disorders
Drooling
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
37.5%
6/16 • Number of events 12
|
|
Nervous system disorders
Headache
|
25.0%
4/16 • Number of events 10
|
|
Nervous system disorders
Leukoencephalopathy
|
6.2%
1/16 • Number of events 3
|
|
Nervous system disorders
Neuropathy
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
4/16 • Number of events 11
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Number of events 3
|
|
Psychiatric disorders
Confusional state
|
12.5%
2/16 • Number of events 4
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Number of events 3
|
|
Psychiatric disorders
Hallucination, visual
|
6.2%
1/16 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
18.8%
3/16 • Number of events 12
|
|
Renal and urinary disorders
Chromaturia
|
6.2%
1/16 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
6.2%
1/16 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
2/16 • Number of events 2
|
|
Reproductive system and breast disorders
Penis disorder
|
6.2%
1/16 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
43.8%
7/16 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.2%
1/16 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
43.8%
7/16 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
18.8%
3/16 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
18.8%
3/16 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
12.5%
2/16 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
12.5%
2/16 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
18.8%
3/16 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
18.8%
3/16 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
6.2%
1/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
6.2%
1/16 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
4/16 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
2/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
6.2%
1/16 • Number of events 3
|
|
Vascular disorders
Hypertension
|
25.0%
4/16 • Number of events 6
|
|
Vascular disorders
Hypotension
|
25.0%
4/16 • Number of events 12
|
|
Vascular disorders
Orthostatic hypotension
|
6.2%
1/16 • Number of events 3
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place