Trial Outcomes & Findings for Bevacizumab and Combination Chemotherapy Before Surgery in Treating Patients With Locally Advanced Esophageal or Stomach Cancer (NCT NCT01212822)
NCT ID: NCT01212822
Last Updated: 2022-09-07
Results Overview
To investigate 2 year disease free survival in pts with resectable esophageal and GE junction cancer treated with perioperative bevaciumab and FOLFOX
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
2 years
Results posted on
2022-09-07
Participant Flow
Participant milestones
| Measure |
Treatment (Bevacizumab, FOLFOX)
NEOADJUVANT THERAPY: Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46 hours on days 1-2. Treatment with bevacizumab repeats every 2 weeks for 4 courses and treatment with FOLFOX repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Patients then undergo planned surgical resection 4-6 weeks after 6 courses of chemotherapy and at least 8 weeks since the last dose of bevacizumab.
ADJUVANT THERAPY: Beginning 8-10 weeks after surgery, patients receive bevacizumab IV, oxaliplatin IV, leucovorin calcium IV, and fluorouracil IV as in neoadjuvant therapy. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bevacizumab and Combination Chemotherapy Before Surgery in Treating Patients With Locally Advanced Esophageal or Stomach Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Bevacizumab, FOLFOX)
n=20 Participants
NEOADJUVANT THERAPY: Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46 hours on days 1-2. Treatment with bevacizumab repeats every 2 weeks for 4 courses and treatment with FOLFOX repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Patients then undergo planned surgical resection 4-6 weeks after 6 courses of chemotherapy and at least 8 weeks since the last dose of bevacizumab.
ADJUVANT THERAPY: Beginning 8-10 weeks after surgery, patients receive bevacizumab IV, oxaliplatin IV, leucovorin calcium IV, and fluorouracil IV as in neoadjuvant therapy. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Customized
30-39
|
1 Participants
n=99 Participants
|
|
Age, Customized
40-49
|
1 Participants
n=99 Participants
|
|
Age, Customized
50-59
|
6 Participants
n=99 Participants
|
|
Age, Customized
60-69
|
5 Participants
n=99 Participants
|
|
Age, Customized
70-79
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsTo investigate 2 year disease free survival in pts with resectable esophageal and GE junction cancer treated with perioperative bevaciumab and FOLFOX
Outcome measures
| Measure |
Treatment (Bevacizumab, FOLFOX)
n=20 Participants
NEOADJUVANT THERAPY: Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46 hours on days 1-2. Treatment with bevacizumab repeats every 2 weeks for 4 courses and treatment with FOLFOX repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Patients then undergo planned surgical resection 4-6 weeks after 6 courses of chemotherapy and at least 8 weeks since the last dose of bevacizumab.
ADJUVANT THERAPY: Beginning 8-10 weeks after surgery, patients receive bevacizumab IV, oxaliplatin IV, leucovorin calcium IV, and fluorouracil IV as in neoadjuvant therapy. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Disease-free Survival
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsTo assess, by path examination after surgical resection, complete and partial response to neoadjuvant therapy. Characterized using proportions and 95% confidence intervals.
Outcome measures
| Measure |
Treatment (Bevacizumab, FOLFOX)
n=20 Participants
NEOADJUVANT THERAPY: Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46 hours on days 1-2. Treatment with bevacizumab repeats every 2 weeks for 4 courses and treatment with FOLFOX repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Patients then undergo planned surgical resection 4-6 weeks after 6 courses of chemotherapy and at least 8 weeks since the last dose of bevacizumab.
ADJUVANT THERAPY: Beginning 8-10 weeks after surgery, patients receive bevacizumab IV, oxaliplatin IV, leucovorin calcium IV, and fluorouracil IV as in neoadjuvant therapy. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Complete and Partial Response to Neoadjuvant Therapy Based on the Response Evaluation Criteria in Solid Tumors (RECIST)
|
44.4 percent of patients
Interval 21.5 to 69.2
|
SECONDARY outcome
Timeframe: 4.5 yearsCharacterized using Kaplan-Meier curves.
Outcome measures
| Measure |
Treatment (Bevacizumab, FOLFOX)
n=20 Participants
NEOADJUVANT THERAPY: Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46 hours on days 1-2. Treatment with bevacizumab repeats every 2 weeks for 4 courses and treatment with FOLFOX repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Patients then undergo planned surgical resection 4-6 weeks after 6 courses of chemotherapy and at least 8 weeks since the last dose of bevacizumab.
ADJUVANT THERAPY: Beginning 8-10 weeks after surgery, patients receive bevacizumab IV, oxaliplatin IV, leucovorin calcium IV, and fluorouracil IV as in neoadjuvant therapy. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Survival
|
26.0 months
Interval 23.7 to 51.4
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: One patient who was not evaluated for progression was excluded from PFS analysis
Characterized using Kaplan-Meier curves. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions and a 5 mm absolute increase, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Treatment (Bevacizumab, FOLFOX)
n=19 Participants
NEOADJUVANT THERAPY: Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46 hours on days 1-2. Treatment with bevacizumab repeats every 2 weeks for 4 courses and treatment with FOLFOX repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Patients then undergo planned surgical resection 4-6 weeks after 6 courses of chemotherapy and at least 8 weeks since the last dose of bevacizumab.
ADJUVANT THERAPY: Beginning 8-10 weeks after surgery, patients receive bevacizumab IV, oxaliplatin IV, leucovorin calcium IV, and fluorouracil IV as in neoadjuvant therapy. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Progression Free Survival
|
19.0 months
Interval 13.1 to
insufficient number of participants with events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to day of surgeryPopulation: Exploratory endpoint, data is not available for analyses
Means, medians, and standard deviations of the biomarker levels and change in biomarker levels within groups defined by response/resistance outcomes will be reported.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Bevacizumab, FOLFOX)
Serious events: 11 serious events
Other events: 20 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Treatment (Bevacizumab, FOLFOX)
n=20 participants at risk
NEOADJUVANT THERAPY: Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46 hours on days 1-2. Treatment with bevacizumab repeats every 2 weeks for 4 courses and treatment with FOLFOX repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Patients then undergo planned surgical resection 4-6 weeks after 6 courses of chemotherapy and at least 8 weeks since the last dose of bevacizumab.
ADJUVANT THERAPY: Beginning 8-10 weeks after surgery, patients receive bevacizumab IV, oxaliplatin IV, leucovorin calcium IV, and fluorouracil IV as in neoadjuvant therapy. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
15.0%
3/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Gastrointestinal disorders
Vomitting
|
10.0%
2/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
4/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
General disorders
Dehydration
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Gastrointestinal disorders
Esophageal pain and obstruction
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Investigations
Low potassium
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Gastrointestinal disorders
Pancolitis
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Infections and infestations
c. difficile infection
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Nervous system disorders
Leg numbness and loss of right upper extremity motor strength
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
General disorders
Fever
|
15.0%
3/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Infections and infestations
Purulent drainage
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Gastrointestinal disorders
Esophageal fistula
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Infections and infestations
Urinary tract infection
|
10.0%
2/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Metabolism and nutrition disorders
Loss of appetite
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Infections and infestations
methicillin-susceptible Staphylococcus aureus
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Infections and infestations
Bacteremia
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Vascular disorders
Tri-cupsid endocarditis
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
Other adverse events
| Measure |
Treatment (Bevacizumab, FOLFOX)
n=20 participants at risk
NEOADJUVANT THERAPY: Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46 hours on days 1-2. Treatment with bevacizumab repeats every 2 weeks for 4 courses and treatment with FOLFOX repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Patients then undergo planned surgical resection 4-6 weeks after 6 courses of chemotherapy and at least 8 weeks since the last dose of bevacizumab.
ADJUVANT THERAPY: Beginning 8-10 weeks after surgery, patients receive bevacizumab IV, oxaliplatin IV, leucovorin calcium IV, and fluorouracil IV as in neoadjuvant therapy. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
80.0%
16/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Investigations
Neutrophil count decreased
|
50.0%
10/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Investigations
Platelet count decreased
|
50.0%
10/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Investigations
White blood cell decreased
|
50.0%
10/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
General disorders
Fatigue
|
85.0%
17/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
85.0%
17/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Gastrointestinal disorders
Nausea
|
50.0%
10/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Nervous system disorders
Neuropathy/paresthesia
|
65.0%
13/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
General disorders
Pain
|
65.0%
13/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
12/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Metabolism and nutrition disorders
Weight loss
|
55.0%
11/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Gastrointestinal disorders
Constipation
|
45.0%
9/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Gastrointestinal disorders
Dysphagia
|
40.0%
8/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
35.0%
7/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
30.0%
6/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Gastrointestinal disorders
Vomitting
|
25.0%
5/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Vascular disorders
Hypertension
|
25.0%
5/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
4/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
4/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Nervous system disorders
Dysguesia
|
20.0%
4/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
General disorders
Fever
|
10.0%
2/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
4/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.0%
3/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
15.0%
3/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
15.0%
3/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Gastrointestinal disorders
Stomasitis
|
15.0%
3/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Psychiatric disorders
Depression
|
10.0%
2/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
General disorders
Edema
|
10.0%
2/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
2/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Renal and urinary disorders
Proterinuria
|
10.0%
2/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Vascular disorders
Artery thrombosis
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Cardiac disorders
Brachycardia
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
General disorders
Chills
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Eye disorders
Eye irritation
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Nervous system disorders
Hand foot syndrome
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Gastrointestinal disorders
Heartburn
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
General disorders
Hemorrhage
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hoarsness
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Metabolism and nutrition disorders
Obesity
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Psychiatric disorders
Substance abuse
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Gastrointestinal disorders
Thrush
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Investigations
Alkaline phosphate increased
|
20.0%
4/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Investigations
Aspirate aminotransferase increased
|
15.0%
3/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Investigations
Alanine aminotransferase increased
|
15.0%
3/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Infections and infestations
Infection without neutropenia
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Gastrointestinal disorders
Esophageal dilation
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Gastrointestinal disorders
Esophageal reflux
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
|
Gastrointestinal disorders
Esophageal stenosis
|
5.0%
1/20 • All-cause mortality was assessed up to 4.5 years. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 6 weeks after treatment
|
Additional Information
Protocol Development Coordinator
Fox Chase Cancer Center
Phone: 215-728-4097
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place