Trial Outcomes & Findings for Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis From Colon Cancer With Systemic Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab (NCT NCT00932438)
NCT ID: NCT00932438
Last Updated: 2021-06-11
Results Overview
Tumor response will be determined using Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Response will classified as: Complete response - disappearance of all lesions; Partial response - at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter or 30% reduction of arterial enhancement; Progressive disease - at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest longest diameter recorded since start of treatment or appearance of one or more new lesions greater than 1cm in size; Stable disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since start of treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Months 2, 4 and 6
Results posted on
2021-06-11
Participant Flow
Participant milestones
| Measure |
Irinotecan Beads With FOLFOX6
LC bead loaded with Irinotecan: Chemoembolization using LC beads loaded with 100mg Irinotecan in combination with Fluorouracil, Oxaliplatin, Leucovorin and Avastin alternating on a 2 week schedule
|
FOLFOX6/Avastin Alone
FOLFOX6 and Avastin: Fluorouracil, Oxaliplatin, Leucovorin and Avastin given biweekly
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
30
|
|
Overall Study
COMPLETED
|
39
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis From Colon Cancer With Systemic Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab
Baseline characteristics by cohort
| Measure |
LC Beads Loaded With Irinotecan and FOLFOX6
n=40 Participants
Device: LC Beads loaded with 100mg Irinotecan
Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician
LC bead loaded with Irinotecan: Chemoembolization using LC beads loaded with 100mg Irinotecan
Oxaliplatin
Leucovorin
5-Fluorouracil
Bevacizumab
|
FOLFOX6 and Bevacizumab
n=30 Participants
Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician
Oxaliplatin
Leucovorin
5-Fluorouracil
Bevacizumab
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
60 years
n=7 Participants
|
58.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Months 2, 4 and 6Population: Intent to treat population: all randomized subjects who received at least one cycle of intravenous chemotherapy or LC bead loaded with irinotecan
Tumor response will be determined using Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Response will classified as: Complete response - disappearance of all lesions; Partial response - at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter or 30% reduction of arterial enhancement; Progressive disease - at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest longest diameter recorded since start of treatment or appearance of one or more new lesions greater than 1cm in size; Stable disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since start of treatment.
Outcome measures
| Measure |
LC Beads Loaded With Irinotecan and FOLFOX6
n=40 Participants
Device: LC Beads loaded with 100mg Irinotecan
Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician
LC bead loaded with Irinotecan: Chemoembolization using LC beads loaded with 100mg Irinotecan
Oxaliplatin
Leucovorin
5-Fluorouracil
Bevacizumab
|
FOLFOX6 and Bevacizumab
n=30 Participants
Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician
Oxaliplatin
Leucovorin
5-Fluorouracil
Bevacizumab
|
|---|---|---|
|
Tumor Response
|
31 participants
|
16 participants
|
SECONDARY outcome
Timeframe: First treatment through one year post treatment completionPopulation: Any subject who received at least one bead treatment in Arm 1 and any subject who received at least one dose of chemotherapy in Arm 2
Total number of serious adverse events that occurred in both Arms of the study.
Outcome measures
| Measure |
LC Beads Loaded With Irinotecan and FOLFOX6
n=40 Participants
Device: LC Beads loaded with 100mg Irinotecan
Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician
LC bead loaded with Irinotecan: Chemoembolization using LC beads loaded with 100mg Irinotecan
Oxaliplatin
Leucovorin
5-Fluorouracil
Bevacizumab
|
FOLFOX6 and Bevacizumab
n=30 Participants
Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician
Oxaliplatin
Leucovorin
5-Fluorouracil
Bevacizumab
|
|---|---|---|
|
Number of Serious Adverse Events
|
49 Serious Adverse Event
|
21 Serious Adverse Event
|
Adverse Events
LC Beads Loaded With Irinotecan and FOLFOX6
Serious events: 40 serious events
Other events: 40 other events
Deaths: 30 deaths
FOLFOX6 and Bevacizumab
Serious events: 20 serious events
Other events: 30 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
LC Beads Loaded With Irinotecan and FOLFOX6
n=40 participants at risk
Device: LC Beads loaded with 100mg Irinotecan
Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician
LC bead loaded with Irinotecan: Chemoembolization using LC beads loaded with 100mg Irinotecan
Oxaliplatin
Leucovorin
5-Fluorouracil
Bevacizumab
|
FOLFOX6 and Bevacizumab
n=30 participants at risk
Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician
Oxaliplatin
Leucovorin
5-Fluorouracil
Bevacizumab
|
|---|---|---|
|
Renal and urinary disorders
GU Obstruction
|
5.0%
2/40 • Number of events 2
|
6.7%
2/30 • Number of events 2
|
|
Vascular disorders
PRES Syndrome
|
7.5%
3/40 • Number of events 3
|
0.00%
0/30
|
|
Gastrointestinal disorders
Nausea
|
7.5%
3/40 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
Bowel Obstruction
|
7.5%
3/40 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure
|
10.0%
4/40 • Number of events 4
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
Necrotizing Cholecystitis
|
2.5%
1/40 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Abdominal Pain
|
17.5%
7/40 • Number of events 7
|
20.0%
6/30 • Number of events 6
|
|
Vascular disorders
Hypertension
|
10.0%
4/40 • Number of events 4
|
3.3%
1/30 • Number of events 1
|
|
Immune system disorders
Allergic Reaction
|
5.0%
2/40 • Number of events 2
|
0.00%
0/30
|
|
Gastrointestinal disorders
Colonic Portal Obstruction
|
2.5%
1/40 • Number of events 1
|
0.00%
0/30
|
|
General disorders
Hypokalemia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/30
|
|
General disorders
Confusion
|
2.5%
1/40 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Bowel Perforation
|
2.5%
1/40 • Number of events 1
|
0.00%
0/30
|
|
General disorders
Dehydration
|
15.0%
6/40 • Number of events 6
|
0.00%
0/30
|
|
Gastrointestinal disorders
Pancreatitis
|
6.7%
2/30 • Number of events 2
|
0.00%
0/30
|
|
Infections and infestations
Sepsis
|
7.5%
3/40 • Number of events 3
|
0.00%
0/30
|
|
Infections and infestations
Viral Respiratory Infection
|
2.5%
1/40 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Ileus
|
2.5%
1/40 • Number of events 1
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Pain Back
|
2.5%
1/40 • Number of events 1
|
0.00%
0/30
|
|
Blood and lymphatic system disorders
Thrombus
|
0.00%
0/40
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Fever
|
2.5%
1/40 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Small Bowel Fistula
|
0.00%
0/40
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Emboli
|
0.00%
0/40
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
Colostomy Perforation
|
0.00%
0/40
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Cholecystitis
|
5.0%
2/40 • Number of events 2
|
0.00%
0/30
|
|
Cardiac disorders
Chest Pain
|
2.5%
1/40 • Number of events 1
|
0.00%
0/30
|
|
Blood and lymphatic system disorders
Groin Hematoma
|
2.5%
1/40 • Number of events 1
|
0.00%
0/30
|
|
Cardiac disorders
Tachycardia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/30
|
|
General disorders
Weakness
|
5.0%
2/40 • Number of events 2
|
0.00%
0/30
|
|
Blood and lymphatic system disorders
Hypokalemia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/30
|
Other adverse events
| Measure |
LC Beads Loaded With Irinotecan and FOLFOX6
n=40 participants at risk
Device: LC Beads loaded with 100mg Irinotecan
Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician
LC bead loaded with Irinotecan: Chemoembolization using LC beads loaded with 100mg Irinotecan
Oxaliplatin
Leucovorin
5-Fluorouracil
Bevacizumab
|
FOLFOX6 and Bevacizumab
n=30 participants at risk
Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician
Oxaliplatin
Leucovorin
5-Fluorouracil
Bevacizumab
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
30.0%
12/40 • Number of events 12
|
13.3%
4/30 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea
|
22.5%
9/40 • Number of events 9
|
20.0%
6/30 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
4/40 • Number of events 4
|
13.3%
4/30 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
22.5%
9/40 • Number of events 9
|
13.3%
4/30 • Number of events 4
|
|
Gastrointestinal disorders
abdominal Pain
|
22.5%
9/40 • Number of events 9
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
15.0%
6/40 • Number of events 6
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
4/40 • Number of events 4
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
5.0%
2/40 • Number of events 2
|
0.00%
0/30
|
|
Psychiatric disorders
Insomnia
|
5.0%
2/40 • Number of events 2
|
16.7%
5/30 • Number of events 5
|
|
Psychiatric disorders
Depression
|
5.0%
2/40 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
10.0%
4/40 • Number of events 4
|
0.00%
0/30
|
|
Psychiatric disorders
Altered Mental Status
|
10.0%
4/40 • Number of events 4
|
0.00%
0/30
|
|
Immune system disorders
Allergic Reaction
|
2.5%
1/40 • Number of events 1
|
10.0%
3/30 • Number of events 3
|
|
Immune system disorders
Herpes Zoster
|
7.5%
3/40 • Number of events 3
|
0.00%
0/30
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
4/40 • Number of events 4
|
16.7%
5/30 • Number of events 5
|
|
Cardiac disorders
Tachycardia
|
10.0%
4/40 • Number of events 4
|
6.7%
2/30 • Number of events 2
|
|
Cardiac disorders
Arrythmia
|
5.0%
2/40 • Number of events 2
|
0.00%
0/30
|
|
Vascular disorders
Hypertension
|
20.0%
8/40 • Number of events 8
|
20.0%
6/30 • Number of events 6
|
|
Vascular disorders
Increased Blood Pressure
|
27.5%
11/40 • Number of events 11
|
6.7%
2/30 • Number of events 2
|
|
Vascular disorders
Pulmonary Emboli
|
2.5%
1/40 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
|
Psychiatric disorders
Somnolence
|
5.0%
2/40 • Number of events 2
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
4/40 • Number of events 4
|
10.0%
3/30 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
1/40 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
|
General disorders
Fatigue
|
40.0%
16/40 • Number of events 16
|
50.0%
15/30 • Number of events 15
|
|
General disorders
Decreased Appetite
|
5.0%
2/40 • Number of events 2
|
0.00%
0/30
|
|
General disorders
Weight Loss
|
10.0%
4/40 • Number of events 4
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Chest Pain
|
7.5%
3/40 • Number of events 3
|
0.00%
0/30
|
|
General disorders
Chills
|
7.5%
3/40 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Edema
|
5.0%
2/40 • Number of events 2
|
6.7%
2/30 • Number of events 2
|
|
Investigations
Thrombocytopenia
|
17.5%
7/40 • Number of events 7
|
6.7%
2/30 • Number of events 2
|
|
Investigations
Hypokalemia
|
10.0%
4/40 • Number of events 4
|
10.0%
3/30 • Number of events 3
|
|
Investigations
Neutropenia
|
15.0%
6/40 • Number of events 6
|
23.3%
7/30 • Number of events 7
|
|
Investigations
Hyperbilirubinemia
|
5.0%
2/40 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Hyponatremia
|
7.5%
3/40 • Number of events 3
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
5.0%
2/40 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.0%
2/40 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.0%
2/40 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
2/40 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.5%
7/40 • Number of events 7
|
30.0%
9/30 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Dysphagia
|
5.0%
2/40 • Number of events 2
|
6.7%
2/30 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
2/40 • Number of events 2
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
5.0%
2/40 • Number of events 2
|
6.7%
2/30 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Stomatitis
|
10.0%
4/40 • Number of events 4
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/40
|
16.7%
5/30 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.5%
9/40 • Number of events 9
|
20.0%
6/30 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.5%
9/40 • Number of events 9
|
13.3%
4/30 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.0%
2/40 • Number of events 2
|
10.0%
3/30 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
5.0%
2/40 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/40
|
6.7%
2/30 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
22.5%
9/40 • Number of events 9
|
3.3%
1/30 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
15.0%
6/40 • Number of events 6
|
6.7%
2/30 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/40
|
16.7%
5/30 • Number of events 5
|
|
Nervous system disorders
Headache
|
10.0%
4/40 • Number of events 4
|
6.7%
2/30 • Number of events 2
|
|
Metabolism and nutrition disorders
Neuropathy
|
40.0%
16/40 • Number of events 16
|
76.7%
23/30 • Number of events 23
|
|
Nervous system disorders
Dizziness
|
5.0%
2/40 • Number of events 2
|
10.0%
3/30 • Number of events 3
|
|
Nervous system disorders
Parasthesia
|
10.0%
4/40 • Number of events 4
|
13.3%
4/30 • Number of events 4
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/40
|
6.7%
2/30 • Number of events 2
|
|
Renal and urinary disorders
Dysuria
|
5.0%
2/40 • Number of events 2
|
0.00%
0/30
|
|
Hepatobiliary disorders
Ascites
|
5.0%
2/40 • Number of events 2
|
0.00%
0/30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place