Trial Outcomes & Findings for Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Gastric Cardia (NCT NCT00591123)
NCT ID: NCT00591123
Last Updated: 2021-10-01
Results Overview
Per response evaluation criteria in solid tumors criteria (RECIST) for target lesions and assessed by computerized tomography (CT) scan. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
3.5 years
Results posted on
2021-10-01
Participant Flow
Participant milestones
| Measure |
FOLFOX Plus 5-FU and Erlotinib
FOLFOX and Erlotinib: Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions, after which 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Gastric Cardia
Baseline characteristics by cohort
| Measure |
FOLFOX Plus 5-FU and Erlotinib
n=38 Participants
FOLFOX and Erlotinib: Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions, after which 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
|
Eastern Cooperative Group performance status
0
|
23 participants
n=5 Participants
|
|
Eastern Cooperative Group performance status
1
|
15 participants
n=5 Participants
|
|
Previous Treatment: Surgery
yes
|
5 participants
n=5 Participants
|
|
Previous Treatment: Surgery
no
|
33 participants
n=5 Participants
|
|
Previous Treatment Chemotherapy
Neoadjuvant
|
8 participants
n=5 Participants
|
|
Previous Treatment Chemotherapy
Adjuvant
|
30 participants
n=5 Participants
|
|
Previous Chemotherapy Regimens
Fluoropyrim/platinum (w/ adjuvant radiation)
|
2 participants
n=5 Participants
|
|
Previous Chemotherapy Regimens
Cisplatin/5-FU based (with neoadjuvant radiation)
|
4 participants
n=5 Participants
|
|
Previous Chemotherapy Regimens
Epirubicin/cisplatin/5-FU
|
2 participants
n=5 Participants
|
|
Previous Chemotherapy Regimens
None
|
30 participants
n=5 Participants
|
|
Previous radiation therapy
yes
|
6 participants
n=5 Participants
|
|
Previous radiation therapy
no
|
32 participants
n=5 Participants
|
|
Neoadjuvant vs. Adjuvant Previous Radiation Therapy
Neoadjuvant
|
4 participants
n=5 Participants
|
|
Neoadjuvant vs. Adjuvant Previous Radiation Therapy
Adjuvant
|
2 participants
n=5 Participants
|
|
Neoadjuvant vs. Adjuvant Previous Radiation Therapy
None
|
32 participants
n=5 Participants
|
|
Oesophagus vs. gastro-oesophageal junction
Oesophagus
|
12 participants
n=5 Participants
|
|
Oesophagus vs. gastro-oesophageal junction
gastro-oesophageal junction (GEJ)
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3.5 yearsPopulation: 33 patients who were evaluable for response per protocol
Per response evaluation criteria in solid tumors criteria (RECIST) for target lesions and assessed by computerized tomography (CT) scan. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Outcome measures
| Measure |
FOLFOX Plus 5-FU and Erlotinib
n=33 Participants
FOLFOX and Erlotinib: Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions, after which 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.
|
|---|---|
|
Overall Response Rate of Previously-untreated Patients With Unresectable or Metastatic Adenocarcinomas of the Upper Gastrointestinal Tract When Treated With the Combination of 5-fluorouracil, Leucovorin, Oxaliplatin, and Erlotinib.
|
51.5 percent of subjects that had response
|
SECONDARY outcome
Timeframe: 3.5 yearsPopulation: Number of subjects that experienced Grade 3 and 4 Adverse events associated with FOLFOX/5-FU/Erlotinib therapy
Adverse event assessment by investigators and as reported by subjects from time of consent to 30 days after last dose. Up to 3.5 years.
Outcome measures
| Measure |
FOLFOX Plus 5-FU and Erlotinib
n=38 Participants
FOLFOX and Erlotinib: Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions, after which 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.
|
|---|---|
|
Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib
Diarrhea / dehydration
|
9 participants
|
|
Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib
Anorexia
|
5 participants
|
|
Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib
Nausea/Vomiting
|
4 participants
|
|
Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib
Rash
|
3 participants
|
|
Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib
Fatigue
|
4 participants
|
|
Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib
Peripheral neuropathy
|
3 participants
|
|
Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib
Neutropenia
|
5 participants
|
|
Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib
Neutropenic Fever
|
1 participants
|
|
Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib
Hypokalemia
|
2 participants
|
|
Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib
AST / ALT Elevation
|
2 participants
|
Adverse Events
Single Arm
Serious events: 7 serious events
Other events: 38 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Single Arm
n=38 participants at risk
FOLFOX and Erlotinib: Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions, after which 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.
|
|---|---|
|
Infections and infestations
Neutropenic Fever
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Infections and infestations
Septic Shock
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Malnutrition
|
5.3%
2/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Nausea
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Gastrointestinal disorders
Diarrhea
|
7.9%
3/38 • Number of events 3 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Nervous system disorders
Altered Mental State
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Renal and urinary disorders
Renal Failure
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Renal and urinary disorders
Inability to Urinate
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Musculoskeletal and connective tissue disorders
Intractable Back Pain
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Injury, poisoning and procedural complications
Sacral Fracture
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Injury, poisoning and procedural complications
Cranial Hematoma
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Infections and infestations
Finger Infection
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Renal and urinary disorders
Hematuria
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Elevated International Normalized Ratio (INR)
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Abdominal Pain
|
2.6%
1/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Surgical and medical procedures
diskectomy
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
Other adverse events
| Measure |
Single Arm
n=38 participants at risk
FOLFOX and Erlotinib: Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions, after which 5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home. All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distention
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Alkaline Phosphatase - elevated
|
28.9%
11/38 • Number of events 13 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Alopecia
|
15.8%
6/38 • Number of events 7 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Alanine Aminotransferase - elevated
|
15.8%
6/38 • Number of events 7 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Anemia
|
42.1%
16/38 • Number of events 19 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Metabolism and nutrition disorders
Anorexia
|
55.3%
21/38 • Number of events 24 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Aspartate Aminotransferase - elevated
|
23.7%
9/38 • Number of events 12 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Eye disorders
Blepharitis
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Bloating
|
13.2%
5/38 • Number of events 6 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Gastrointestinal disorders
Blood in stool
|
5.3%
2/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Eye disorders
Blurred vision
|
5.3%
2/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Cachexia
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Cardiac disorders
Cardiac infarction
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Vascular disorders
Cerebrovascular accident (CVA)
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Chills
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Cold sensitivity
|
13.2%
5/38 • Number of events 5 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Cold-like symptoms
|
7.9%
3/38 • Number of events 5 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Constipation
|
36.8%
14/38 • Number of events 14 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.8%
6/38 • Number of events 6 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Cramps - limbs
|
7.9%
3/38 • Number of events 3 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Creatinine - elevated
|
5.3%
2/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Dehydration
|
36.8%
14/38 • Number of events 15 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Diabetes mellitus
|
2.6%
1/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Diaphoresis
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Gastrointestinal disorders
Diarrhea
|
73.7%
28/38 • Number of events 53 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Dizziness
|
10.5%
4/38 • Number of events 5 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Dry eye
|
5.3%
2/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Dry heaves
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Dry mouth
|
10.5%
4/38 • Number of events 4 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Dry Nose
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Dry skin
|
23.7%
9/38 • Number of events 10 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Dyspepsia
|
7.9%
3/38 • Number of events 5 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Dysphagia
|
13.2%
5/38 • Number of events 6 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.3%
10/38 • Number of events 10 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Edema
|
18.4%
7/38 • Number of events 12 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Esophagitis
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Facial flushing
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Fatigue
|
63.2%
24/38 • Number of events 37 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Fever
|
5.3%
2/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Gastrointestinal disorders
Flatulence
|
7.9%
3/38 • Number of events 4 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Flu-like syndrome
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Folliculitis
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Gait-Walking
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Gastrointestinal disorders
GERD
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Glossitis
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Hand and Foot Syndrome
|
7.9%
3/38 • Number of events 4 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Gastrointestinal disorders
Heart burn
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Gastrointestinal disorders
Hematemesis
|
5.3%
2/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Vascular disorders
Hematoma
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Renal and urinary disorders
Hematuria
|
5.3%
2/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Hemorrhage (GI, gums, nose, upper GI)
|
13.2%
5/38 • Number of events 5 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Hemorrhage (nose, oral cavity)
|
5.3%
2/38 • Number of events 4 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Gastrointestinal disorders
Hemorrhoid
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Hiccups
|
5.3%
2/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Metabolism and nutrition disorders
Hot flashes
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Hyperalbuminemia
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
10.5%
4/38 • Number of events 7 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Hypercholesterolemia
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
23.7%
9/38 • Number of events 11 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Hypertension
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
18.4%
7/38 • Number of events 8 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
18.4%
7/38 • Number of events 8 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Hypokalemia
|
44.7%
17/38 • Number of events 24 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Hypomagnesia
|
5.3%
2/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Hyponatremia
|
13.2%
5/38 • Number of events 6 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Hypotension
|
10.5%
4/38 • Number of events 5 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Hypothermia
|
5.3%
2/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Hypoxia
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Infections and infestations
Infection
|
26.3%
10/38 • Number of events 15 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Infections and infestations
Infection (skin, upper airway, pneumonia)
|
10.5%
4/38 • Number of events 4 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
International Normalized Ratio (INR) - elevated
|
5.3%
2/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Hepatobiliary disorders
Jaundice
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion - Elbow
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Lactose intolerance
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
39.5%
15/38 • Number of events 24 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
15.8%
6/38 • Number of events 11 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Mental status
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Mood alteration - anxiety
|
18.4%
7/38 • Number of events 7 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Mood alteration - depression
|
15.8%
6/38 • Number of events 9 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Mucositis - oral cavity
|
39.5%
15/38 • Number of events 17 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Musculoskeletal and connective tissue disorders
Myotonia
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Nail Changes
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Nausea
|
55.3%
21/38 • Number of events 31 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Nervous system disorders
Neuropathy
|
5.3%
2/38 • Number of events 3 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Nervous system disorders
Neuropathy - motor
|
2.6%
1/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Nervous system disorders
Neuropathy - sensory
|
57.9%
22/38 • Number of events 38 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
36.8%
14/38 • Number of events 32 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Neutropenic fever
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Night sweats
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Gastrointestinal disorders
Obstruction - GI small bowel NOS
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Eye disorders
Ocular - drainage
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Eye disorders
Ocular - ruptured vessel
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Ear and labyrinth disorders
Odynophagia
|
5.3%
2/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Pain
|
76.3%
29/38 • Number of events 48 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Skin and subcutaneous tissue disorders
Pallor
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Cardiac disorders
Palpitation
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Gastrointestinal disorders
Perforation gastrointestinal tract
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Performance Status Decrease
|
7.9%
3/38 • Number of events 4 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.9%
3/38 • Number of events 3 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
78.9%
30/38 • Number of events 55 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Renal and urinary disorders
Renal failure
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Ear and labyrinth disorders
Rhinitis
|
5.3%
2/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Rigors-Chills
|
7.9%
3/38 • Number of events 3 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Sepsis
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Serum Chloride - Decrease
|
5.3%
2/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Serum Protein - Decreased
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Ear and labyrinth disorders
Sinusitis
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation - portacath site
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Skin and subcutaneous tissue disorders
Papule lower extremities
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Skin and subcutaneous tissue disorders
Papule upper chest
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Somnolence
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Stomatitis
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Sweating
|
5.3%
2/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Syncope
|
5.3%
2/38 • Number of events 2 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Cardiac disorders
Tachycardia
|
13.2%
5/38 • Number of events 6 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Taste alteration
|
13.2%
5/38 • Number of events 7 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Vascular disorders
Thrombosis-Embolism
|
7.9%
3/38 • Number of events 5 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Infections and infestations
Thrush
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Urinary retention
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.3%
2/38 • Number of events 3 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Voice changes
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Vomiting
|
42.1%
16/38 • Number of events 22 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Weakness
|
26.3%
10/38 • Number of events 15 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
General disorders
Weight loss
|
44.7%
17/38 • Number of events 22 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.6%
1/38 • Number of events 1 • consent until 30 days post treatment
Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment Period.
|
Additional Information
Zev Wainberg, MD
UCLA GI Oncology Program, David Geffen School of Medicine at UCLA
Phone: 310-829-5471
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place