Trial Outcomes & Findings for Sorafenib With Capecitabine for Patients With Measurable Hepatocellular Carcinoma (NCT NCT01032850)
NCT ID: NCT01032850
Last Updated: 2021-06-02
Results Overview
The primary objective of the study is to evaluate safety and tolerability of the study treatment regimen. The analyses will be descriptive and no formal hypotheses testing will be performed. Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
6 months
Results posted on
2021-06-02
Participant Flow
56 participants were screened. 39 did not meet criteria; 2 refused study entry. 15 participants were enrolled.
Participant milestones
| Measure |
Arm 1: Sorafenib & Capecitabine
Intervention: Sorafenib \& Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)
Sorafenib \& Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sorafenib With Capecitabine for Patients With Measurable Hepatocellular Carcinoma
Baseline characteristics by cohort
| Measure |
Arm 1: Sorafenib & Capecitabine
n=13 Participants
Intervention: Sorafenib \& Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)
Sorafenib \& Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days.
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe primary objective of the study is to evaluate safety and tolerability of the study treatment regimen. The analyses will be descriptive and no formal hypotheses testing will be performed. Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit.
Outcome measures
| Measure |
Arm 1: Sorafenib & Capecitabine
n=13 Participants
Intervention: Sorafenib \& Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)
Sorafenib \& Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days.
|
|---|---|
|
Number of Participants Experiencing Adverse Events
Thrombocytopenia
|
9 participants
|
|
Number of Participants Experiencing Adverse Events
Neutropenia
|
1 participants
|
|
Number of Participants Experiencing Adverse Events
Low phosphate levels
|
3 participants
|
|
Number of Participants Experiencing Adverse Events
Low magnesium levels
|
2 participants
|
|
Number of Participants Experiencing Adverse Events
Low calcium levels
|
2 participants
|
|
Number of Participants Experiencing Adverse Events
Low sodium levels
|
1 participants
|
|
Number of Participants Experiencing Adverse Events
High bilirubin levels
|
3 participants
|
|
Number of Participants Experiencing Adverse Events
Elevated aspartate aminotransferase
|
2 participants
|
|
Number of Participants Experiencing Adverse Events
Hand and foot syndrome
|
3 participants
|
|
Number of Participants Experiencing Adverse Events
Mucositis
|
1 participants
|
|
Number of Participants Experiencing Adverse Events
Alopecia (Hair loss)
|
1 participants
|
|
Number of Participants Experiencing Adverse Events
Skin rash
|
1 participants
|
|
Number of Participants Experiencing Adverse Events
Deep vein thrombosis
|
3 participants
|
|
Number of Participants Experiencing Adverse Events
Treatment related deaths
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsTumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Disease control rate (DCR) is the sum of the percentages of patients achieving complete and partial responses and stable disease
Outcome measures
| Measure |
Arm 1: Sorafenib & Capecitabine
n=13 Participants
Intervention: Sorafenib \& Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)
Sorafenib \& Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days.
|
|---|---|
|
Disease Control Rate of Response (DCR)
Complete Response (CR)
|
8 percentage of participants
|
|
Disease Control Rate of Response (DCR)
Partial Response (PR)
|
8 percentage of participants
|
|
Disease Control Rate of Response (DCR)
Stable Disease (SD)
|
61 percentage of participants
|
|
Disease Control Rate of Response (DCR)
Disease Control Rate of Response (DCR)
|
77 percentage of participants
|
SECONDARY outcome
Timeframe: 5 yearsThe time from treatment initiation to death by any cause
Outcome measures
| Measure |
Arm 1: Sorafenib & Capecitabine
n=13 Participants
Intervention: Sorafenib \& Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)
Sorafenib \& Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days.
|
|---|---|
|
Overall Survival (OS)
|
12.7 Months
Interval 8.5 to 23.4
|
SECONDARY outcome
Timeframe: 5 yearsThe time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Arm 1: Sorafenib & Capecitabine
n=13 Participants
Intervention: Sorafenib \& Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)
Sorafenib \& Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days.
|
|---|---|
|
Progression Free Survival (PFS)
|
4.15 months
Interval 2.1 to 5.5
|
Adverse Events
Arm 1: Sorafenib & Capecitabine
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Sorafenib & Capecitabine
n=13 participants at risk
Intervention: Sorafenib \& Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)
Sorafenib \& Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
General disorders
Fatigue
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
General disorders
Fever
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia (Low sodium levels)
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia (lack of appetite)
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
General disorders
Death
|
7.7%
1/13 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Arm 1: Sorafenib & Capecitabine
n=13 participants at risk
Intervention: Sorafenib \& Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)
Sorafenib \& Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days.
|
|---|---|
|
Eye disorders
Blurred Vision
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Eye disorders
Eye disorders - other
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
2/13 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Ascites (Accumulation of fluid in the abdomen)
|
46.2%
6/13 • Number of events 12 • 3 years
|
|
Gastrointestinal disorders
Oral hemorrhage (bleeding gums)
|
15.4%
2/13 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
69.2%
9/13 • Number of events 18 • 3 years
|
|
Gastrointestinal disorders
Dyspepsia (Heartburn)
|
23.1%
3/13 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Mucositis: oral (Mouth inflammation)
|
23.1%
3/13 • Number of events 6 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
46.2%
6/13 • Number of events 11 • 3 years
|
|
Gastrointestinal disorders
Rectal bleeding
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
3/13 • Number of events 7 • 3 years
|
|
General disorders
Edema
|
15.4%
2/13 • Number of events 2 • 3 years
|
|
General disorders
Edema: face
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
General disorders
Edema: limb
|
38.5%
5/13 • Number of events 8 • 3 years
|
|
General disorders
Fatigue
|
53.8%
7/13 • Number of events 17 • 3 years
|
|
General disorders
Flu like symptoms
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
General disorders
Hepatotoxicity
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Infections and infestations
Mucosal Infection
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Infections and infestations
Respiratory infection
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Infections and infestations
Skin infection
|
15.4%
2/13 • Number of events 4 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Hernia surgery
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Hernia surgery repair
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Investigations
Alkaline phosphatase increased
|
15.4%
2/13 • Number of events 2 • 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
23.1%
3/13 • Number of events 5 • 3 years
|
|
Investigations
Elevated bilirubin
|
23.1%
3/13 • Number of events 13 • 3 years
|
|
Investigations
Elevated creatinine
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Investigations
Hemoglobin decreased
|
7.7%
1/13 • Number of events 6 • 3 years
|
|
Investigations
Hyperglycemia (Increased blood glucose)
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Investigations
Hypoalbuminemia (Decreased albumin levels)
|
30.8%
4/13 • Number of events 7 • 3 years
|
|
Investigations
Hypocalcemia (Decreased calcium levels)
|
23.1%
3/13 • Number of events 5 • 3 years
|
|
Investigations
Hypokalemia (Decreased postassium levels)
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Investigations
Hypomagnesemia (Decreased magnesium levels)
|
15.4%
2/13 • Number of events 7 • 3 years
|
|
Investigations
Hyponatremia (Decreased sodium levels)
|
46.2%
6/13 • Number of events 8 • 3 years
|
|
Investigations
Hypophosphatemia (Decreased phosphate levels)
|
30.8%
4/13 • Number of events 7 • 3 years
|
|
Investigations
Increased Bilirubin
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Investigations
Laboratory abnormality - Other
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Investigations
Leukocytes decreased
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Investigations
Neutrophils decreased
|
15.4%
2/13 • Number of events 4 • 3 years
|
|
Investigations
Platelets decreased
|
30.8%
4/13 • Number of events 22 • 3 years
|
|
Metabolism and nutrition disorders
Weight loss
|
53.8%
7/13 • Number of events 10 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia (Loss of appetite)
|
23.1%
3/13 • Number of events 4 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
23.1%
3/13 • Number of events 3 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • Number of events 2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremities
|
15.4%
2/13 • Number of events 2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain: Other
|
30.8%
4/13 • Number of events 9 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
15.4%
2/13 • Number of events 2 • 3 years
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Nervous system disorders
Neuropathy
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Nervous system disorders
Paresthesia (Numbness, tingling)
|
15.4%
2/13 • Number of events 3 • 3 years
|
|
Psychiatric disorders
Altered mental state
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Nervous system disorders
Confusion
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Insomnia
|
23.1%
3/13 • Number of events 3 • 3 years
|
|
Renal and urinary disorders
Urinary retention
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (Shortness of breath)
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis (Nosebleed)
|
30.8%
4/13 • Number of events 4 • 3 years
|
|
Reproductive system and breast disorders
Hypoxia (low blood oxygen)
|
15.4%
2/13 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other
|
7.7%
1/13 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia (Hair loss)
|
23.1%
3/13 • Number of events 3 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
15.4%
2/13 • Number of events 2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Flushing
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Hand and foot syndrome
|
46.2%
6/13 • Number of events 16 • 3 years
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
23.1%
3/13 • Number of events 3 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritis (Itching)
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.8%
4/13 • Number of events 4 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
7.7%
1/13 • Number of events 2 • 3 years
|
|
Vascular disorders
Deep vein thrombosis
|
15.4%
2/13 • Number of events 2 • 3 years
|
|
Vascular disorders
Hypertension (High blood pressure)
|
30.8%
4/13 • Number of events 6 • 3 years
|
|
Vascular disorders
Hypotension (Low blood pressure)
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Vascular disorders
Intracerebral hemorrhage
|
7.7%
1/13 • Number of events 1 • 3 years
|
Additional Information
Dr. Yehuda Patt, MD
University of New Mexico Cancer Center
Phone: 505-925-0405
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place