Trial Outcomes & Findings for Oxaliplatin, Capecitabine, and Cetuximab in Treating Patients With Advanced Liver Cancer (NCT NCT00483405)
NCT ID: NCT00483405
Last Updated: 2017-07-12
Results Overview
Radiographic response will be measured every six weeks while subject is on treatment. Response will be measured using RECIST criteria. 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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
42 days (2 cycles)
Results posted on
2017-07-12
Participant Flow
Of the 33 enrolled; 2 patients withdrew or refused prior to the beginning of protocol therapy, 2 patients were found to be ineligible, and 1 patient was withdrawn when diagnosis changed to sarcoma.
Participant milestones
| Measure |
Single Arm Trial
Single Arm Trial
cetuximab: 250 mg/m2, intravenously, once per week
capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Single Arm Trial
Single Arm Trial
cetuximab: 250 mg/m2, intravenously, once per week
capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Lack of Efficacy
|
14
|
|
Overall Study
Death
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Other complicating disease
|
1
|
Baseline Characteristics
Childs-Pugh was available only for the 24 evaluable patients.
Baseline characteristics by cohort
| Measure |
Single Arm Trial
n=28 Participants
Single Arm Trial
cetuximab: 250 mg/m2, intravenously, once per week
capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle
|
|---|---|
|
Age, Continuous
|
59 years
n=28 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=28 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=28 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=28 Participants
|
|
The Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
14 Participants
n=28 Participants
|
|
The Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
12 Participants
n=28 Participants
|
|
The Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
1 Participants
n=28 Participants
|
|
Childs-Pugh Classification
Class A (5-6 points)
|
18 Participants
n=24 Participants • Childs-Pugh was available only for the 24 evaluable patients.
|
|
Childs-Pugh Classification
Class B (7-9 points)
|
6 Participants
n=24 Participants • Childs-Pugh was available only for the 24 evaluable patients.
|
|
Childs-Pugh Classification
Class C (10-15 points)
|
0 Participants
n=28 Participants • Childs-Pugh was available only for the 24 evaluable patients.
|
|
Prior Therapy
Yes
|
13 Participants
n=28 Participants
|
|
Prior Therapy
None
|
15 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: 42 days (2 cycles)Population: Four patients received some protocol treatment but withdrew before completing one cycle without assessment of response.
Radiographic response will be measured every six weeks while subject is on treatment. Response will be measured using RECIST criteria. 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.
Outcome measures
| Measure |
Single Arm Trial
n=24 Participants
Single Arm Trial
cetuximab: 250 mg/m2, intravenously, once per week
capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle
|
|---|---|
|
Disease Response Rate
|
12.5 percentage of participants with response
Interval 3.0 to 32.0
|
SECONDARY outcome
Timeframe: every 3 weeks of treatment with an average of 15 weeks on treatmentAdverse events will be assessed using CTCAE criteria.
Outcome measures
| Measure |
Single Arm Trial
n=29 Participants
Single Arm Trial
cetuximab: 250 mg/m2, intravenously, once per week
capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle
|
|---|---|
|
Number of Subjects Experiencing Adverse Events
|
29 Participants
|
SECONDARY outcome
Timeframe: Median 23 month follow-upPopulation: Four patients received some protocol treatment but withdrew before completing one cycle without assessment of response.
Overall survival will be calculated from time of enrollment to death or last contact date.
Outcome measures
| Measure |
Single Arm Trial
n=24 Participants
Single Arm Trial
cetuximab: 250 mg/m2, intravenously, once per week
capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle
|
|---|---|
|
Overall Survival
|
4.4 months
Interval 2.4 to 7.3
|
SECONDARY outcome
Timeframe: Median 23 month follow-upPopulation: Four patients received some protocol treatment but withdrew before completing one cycle without assessment of response.
Time to progression will be calculated from the time of enrollment until confirmed disease progression. Defined by RECIST (Response Evaluation Criteria in Solid Tumors), Progressive Disease (PD) - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Single Arm Trial
n=24 Participants
Single Arm Trial
cetuximab: 250 mg/m2, intravenously, once per week
capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle
|
|---|---|
|
Time to Progression
|
4.5 months
Interval 3.2 to 6.4
|
Adverse Events
Single Arm Trial
Serious events: 17 serious events
Other events: 27 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Single Arm Trial
n=29 participants at risk
Single Arm Trial
cetuximab: 250 mg/m2, intravenously, once per week
capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
6.9%
2/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
6.9%
2/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Cardiac disorders
Conduction abnormality/atrioventricular heart block - AV Block-Third degree (Complete AV block)
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Psychiatric disorders
Confusion
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Investigations
Creatinine
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.3%
3/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Gastrointestinal disorders
Diarrhea
|
17.2%
5/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
6.9%
2/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
General disorders
Edema: limb
|
6.9%
2/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
General disorders
Edema: viscera
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Nervous system disorders
Encephalopathy
|
17.2%
5/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
10.3%
3/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Esophagus
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Rectum
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Upper GI NOS
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Vascular disorders
Hypotension
|
6.9%
2/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
13.8%
4/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Salivary gland
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Investigations
Leukocytes (total WBC)
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Investigations
Lipase
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
6.9%
2/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
13.8%
4/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Renal and urinary disorders
Renal failure
|
10.3%
3/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __)
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
6.9%
2/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
Other adverse events
| Measure |
Single Arm Trial
n=29 participants at risk
Single Arm Trial
cetuximab: 250 mg/m2, intravenously, once per week
capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle
|
|---|---|
|
Investigations
Albumin, serum-low (hypoalbuminemia)
|
72.4%
21/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Investigations
Alkaline phosphatase
|
62.1%
18/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
51.7%
15/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Metabolism and nutrition disorders
Anorexia
|
37.9%
11/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
62.1%
18/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
48.3%
14/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
65.5%
19/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Gastrointestinal disorders
Constipation
|
24.1%
7/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Investigations
Creatinine
|
31.0%
9/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Gastrointestinal disorders
Diarrhea
|
55.2%
16/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
69.0%
20/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
34.5%
10/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
51.7%
15/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
20.7%
6/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
48.3%
14/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
82.8%
24/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Oral cavity
|
51.7%
15/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Gastrointestinal disorders
Nausea
|
62.1%
18/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Nervous system disorders
Neuropathy: sensory
|
69.0%
20/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
27.6%
8/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
31.0%
9/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Blood and lymphatic system disorders
Platelets
|
51.7%
15/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
34.5%
10/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
55.2%
16/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
20.7%
6/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
37.9%
11/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
|
Gastrointestinal disorders
Vomiting
|
34.5%
10/29 • Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
|
Additional Information
Robin V. Johnson
UNC Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place