Trial Outcomes & Findings for Phase 3 Trial of Litx™ Plus Chemotherapy vs. Chemotherapy Only Treating Colorectal Cancer Patients With Recurrent Liver Metastases (NCT NCT00440310)
NCT ID: NCT00440310
Last Updated: 2015-08-25
Results Overview
Time from randomization to death
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
483 participants
Primary outcome timeframe
Up to 184 weeks
Results posted on
2015-08-25
Participant Flow
Participant milestones
| Measure |
Litx + Chemotherapy
Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.
Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy
FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan
|
Chemotherapy Alone
FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan
|
|---|---|---|
|
Overall Study
STARTED
|
244
|
239
|
|
Overall Study
Treated
|
222
|
232
|
|
Overall Study
COMPLETED
|
216
|
209
|
|
Overall Study
NOT COMPLETED
|
28
|
30
|
Reasons for withdrawal
| Measure |
Litx + Chemotherapy
Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.
Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy
FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan
|
Chemotherapy Alone
FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
15
|
14
|
|
Overall Study
No Reply at EOS
|
7
|
7
|
|
Overall Study
Other
|
1
|
0
|
|
Overall Study
Status Unknown
|
1
|
3
|
Baseline Characteristics
Phase 3 Trial of Litx™ Plus Chemotherapy vs. Chemotherapy Only Treating Colorectal Cancer Patients With Recurrent Liver Metastases
Baseline characteristics by cohort
| Measure |
Litx + Chemotherapy
n=244 Participants
Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.
Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy
FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan
|
Chemotherapy Alone
n=239 Participants
FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan
|
Total
n=483 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
59.7 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Age, Customized
|
60.0 years
n=5 Participants
|
61.0 years
n=7 Participants
|
60.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
137 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 184 weeksPopulation: ITT (All patient randomized/enrolled)
Time from randomization to death
Outcome measures
| Measure |
Litx + Chemotherapy
n=244 Participants
Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.
Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy
FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan
|
Chemotherapy Alone
n=239 Participants
FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan
|
|---|---|---|
|
Overall Survival
|
390 Days
Interval 234.0 to 735.0
|
405 Days
Interval 244.0 to 655.0
|
Adverse Events
Litx + Chemotherapy
Serious events: 66 serious events
Other events: 201 other events
Deaths: 0 deaths
Chemotherapy Alone
Serious events: 52 serious events
Other events: 207 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Litx + Chemotherapy
n=222 participants at risk
Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.
Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy
FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan
|
Chemotherapy Alone
n=232 participants at risk
FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.45%
1/222
|
0.00%
0/232
|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
5/222
|
1.7%
4/232
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.45%
1/222
|
0.00%
0/232
|
|
Gastrointestinal disorders
Ascites
|
0.45%
1/222
|
0.00%
0/232
|
|
General disorders
Asthenia
|
1.4%
3/222
|
0.43%
1/232
|
|
Hepatobiliary disorders
Bile duct obstruction
|
1.4%
3/222
|
0.00%
0/232
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/222
|
0.86%
2/232
|
|
Cardiac disorders
Cardiac failure
|
0.45%
1/222
|
0.00%
0/232
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.45%
1/222
|
0.43%
1/232
|
|
Nervous system disorders
Cerebral ischaemia
|
0.90%
2/222
|
0.00%
0/232
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/222
|
0.43%
1/232
|
|
Hepatobiliary disorders
Cholangitis
|
0.45%
1/222
|
0.00%
0/232
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/222
|
0.43%
1/232
|
|
Gastrointestinal disorders
Constipation
|
0.45%
1/222
|
0.00%
0/232
|
|
General disorders
Death
|
0.45%
1/222
|
0.00%
0/232
|
|
Vascular disorders
Deep vein thrombosis
|
0.45%
1/222
|
0.86%
2/232
|
|
Gastrointestinal disorders
Diarrhoea
|
0.90%
2/222
|
1.3%
3/232
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.45%
1/222
|
0.00%
0/232
|
|
General disorders
Fatigue
|
0.00%
0/222
|
0.43%
1/232
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
3/222
|
0.86%
2/232
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/222
|
0.43%
1/232
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.45%
1/222
|
0.00%
0/232
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/222
|
0.43%
1/232
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/222
|
0.43%
1/232
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.45%
1/222
|
0.43%
1/232
|
|
Hepatobiliary disorders
Haemobilia
|
0.45%
1/222
|
0.00%
0/232
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/222
|
0.43%
1/232
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/222
|
0.43%
1/232
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.45%
1/222
|
0.00%
0/232
|
|
Immune system disorders
Hypersensitivity
|
0.90%
2/222
|
0.00%
0/232
|
|
Gastrointestinal disorders
Ileus
|
0.45%
1/222
|
0.43%
1/232
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.45%
1/222
|
0.43%
1/232
|
|
Infections and infestations
Liver abscess
|
0.90%
2/222
|
0.00%
0/232
|
|
Hepatobiliary disorders
Liver injury
|
0.45%
1/222
|
0.00%
0/232
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/222
|
0.43%
1/232
|
|
Infections and infestations
Malaria
|
0.45%
1/222
|
0.00%
0/232
|
|
Surgical and medical procedures
Malignant tumour excision
|
0.45%
1/222
|
0.00%
0/232
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.45%
1/222
|
0.00%
0/232
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/222
|
0.43%
1/232
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.45%
1/222
|
0.43%
1/232
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to perineum
|
0.00%
0/222
|
0.43%
1/232
|
|
General disorders
Mucosal inflammation
|
0.00%
0/222
|
0.43%
1/232
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/222
|
0.43%
1/232
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
4.5%
10/222
|
5.2%
12/232
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.7%
6/222
|
2.6%
6/232
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/222
|
0.43%
1/232
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.00%
0/222
|
0.43%
1/232
|
|
Infections and infestations
Perirectal abscess
|
0.90%
2/222
|
0.00%
0/232
|
|
Infections and infestations
Pneumonia
|
0.45%
1/222
|
0.43%
1/232
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.45%
1/222
|
0.43%
1/232
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.6%
8/222
|
0.00%
0/232
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.45%
1/222
|
0.43%
1/232
|
|
General disorders
Pyrexia
|
1.8%
4/222
|
0.86%
2/232
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/222
|
0.86%
2/232
|
|
Renal and urinary disorders
Renal failure acute
|
0.45%
1/222
|
0.43%
1/232
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/222
|
0.43%
1/232
|
|
Infections and infestations
Sepsis
|
0.00%
0/222
|
0.43%
1/232
|
|
Infections and infestations
Septic shock
|
0.00%
0/222
|
0.43%
1/232
|
|
Nervous system disorders
Status epilepticus
|
0.45%
1/222
|
0.00%
0/232
|
|
Gastrointestinal disorders
Subileus
|
0.45%
1/222
|
0.43%
1/232
|
|
General disorders
Sudden death
|
1.4%
3/222
|
0.00%
0/232
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.90%
2/222
|
0.00%
0/232
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/222
|
0.43%
1/232
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/222
|
0.43%
1/232
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.45%
1/222
|
0.43%
1/232
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/222
|
0.43%
1/232
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/222
|
0.43%
1/232
|
|
Vascular disorders
Venous thrombosis limb
|
0.45%
1/222
|
0.00%
0/232
|
Other adverse events
| Measure |
Litx + Chemotherapy
n=222 participants at risk
Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.
Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy
FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan
|
Chemotherapy Alone
n=232 participants at risk
FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
39/222
|
15.9%
37/232
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.6%
8/222
|
2.2%
5/232
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
3/222
|
3.0%
7/232
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.3%
14/222
|
4.7%
11/232
|
|
Blood and lymphatic system disorders
Anaemia
|
15.3%
34/222
|
15.1%
35/232
|
|
Psychiatric disorders
Anxiety
|
2.3%
5/222
|
0.86%
2/232
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
7/222
|
0.43%
1/232
|
|
Investigations
Aspartate aminotransferase increased
|
1.8%
4/222
|
3.0%
7/232
|
|
General disorders
Asthenia
|
14.9%
33/222
|
19.0%
44/232
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.4%
23/222
|
3.9%
9/232
|
|
Investigations
Blood albumin decreased
|
3.2%
7/222
|
1.7%
4/232
|
|
Investigations
Blood alkaline phosphatase increased
|
3.2%
7/222
|
1.3%
3/232
|
|
Investigations
Blood pressure increased
|
3.2%
7/222
|
0.86%
2/232
|
|
Surgical and medical procedures
Catheterisation venous
|
5.9%
13/222
|
5.2%
12/232
|
|
General disorders
Chest pain
|
1.4%
3/222
|
2.2%
5/232
|
|
General disorders
Chills
|
1.4%
3/222
|
2.2%
5/232
|
|
Gastrointestinal disorders
Constipation
|
6.8%
15/222
|
5.6%
13/232
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
13/222
|
4.3%
10/232
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.8%
24/222
|
8.6%
20/232
|
|
Gastrointestinal disorders
Diarrhoea
|
18.0%
40/222
|
19.8%
46/232
|
|
Nervous system disorders
Dizziness
|
1.4%
3/222
|
3.0%
7/232
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
4/222
|
2.6%
6/232
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
3/222
|
3.9%
9/232
|
|
Investigations
Eastern cooperative oncology group performance status worsened
|
4.5%
10/222
|
3.0%
7/232
|
|
General disorders
Fatigue
|
21.2%
47/222
|
19.4%
45/232
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.2%
7/222
|
2.2%
5/232
|
|
Nervous system disorders
Headache
|
3.2%
7/222
|
2.6%
6/232
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.7%
6/222
|
1.3%
3/232
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.4%
3/222
|
2.2%
5/232
|
|
Vascular disorders
Hypertension
|
6.3%
14/222
|
2.2%
5/232
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.4%
3/222
|
3.0%
7/232
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
3/222
|
2.6%
6/232
|
|
Vascular disorders
Hypotension
|
0.00%
0/222
|
3.4%
8/232
|
|
Psychiatric disorders
Insomnia
|
3.6%
8/222
|
4.7%
11/232
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.4%
23/222
|
9.1%
21/232
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.2%
7/222
|
2.2%
5/232
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.7%
6/222
|
0.86%
2/232
|
|
Gastrointestinal disorders
Nausea
|
31.1%
69/222
|
28.9%
67/232
|
|
Nervous system disorders
Neuropathy peripheral
|
4.5%
10/222
|
2.6%
6/232
|
|
Blood and lymphatic system disorders
Neutropenia
|
21.6%
48/222
|
18.5%
43/232
|
|
General disorders
Oedema peripheral
|
5.4%
12/222
|
6.0%
14/232
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
4/222
|
2.6%
6/232
|
|
Nervous system disorders
Paraesthesia
|
5.0%
11/222
|
5.2%
12/232
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.5%
10/222
|
8.2%
19/232
|
|
Vascular disorders
Phlebitis
|
2.3%
5/222
|
2.6%
6/232
|
|
Injury, poisoning and procedural complications
Procedural pain
|
50.5%
112/222
|
0.00%
0/232
|
|
General disorders
Pyrexia
|
21.6%
48/222
|
14.7%
34/232
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.45%
1/222
|
2.2%
5/232
|
|
Gastrointestinal disorders
Stomatitis
|
5.0%
11/222
|
3.0%
7/232
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.4%
12/222
|
5.6%
13/232
|
|
Infections and infestations
Urinary tract infection
|
3.6%
8/222
|
3.4%
8/232
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
37/222
|
17.2%
40/232
|
|
Investigations
Weight decreased
|
5.9%
13/222
|
4.7%
11/232
|
Additional Information
Vice President of Regulatory Affairs and Clinical Operations
Light Sciences Oncology, Inc.
Phone: 425-957-8986
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60