Trial Outcomes & Findings for Phase II Trial for Patients With Loco-Regional Esophageal Carcinoma (NCT NCT00570531)
NCT ID: NCT00570531
Last Updated: 2016-05-26
Results Overview
The primary outcome that will be measured is the length of time that patients are alive without recurrence of cancer following this therapy.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
5 years
Results posted on
2016-05-26
Participant Flow
Participant milestones
| Measure |
Bevacizumab
Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.
Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m\^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.
Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m\^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.
5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.
Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Trial for Patients With Loco-Regional Esophageal Carcinoma
Baseline characteristics by cohort
| Measure |
Bevacizumab
n=6 Participants
Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.
Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m\^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.
Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m\^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.
5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.
Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays.
|
|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: The study was unable to accrue the number of patients necessary to analyze the primary objective.
The primary outcome that will be measured is the length of time that patients are alive without recurrence of cancer following this therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: The study was unable to accrue the number of patients necessary to analyze the objective.
Determination of whether the pre-operative treatment can eliminate all the cancer cells at the time of surgery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every three weeks for one yearPopulation: The study was unable to accrue the number of patients necessary to analyze the objective.
To assess the toxicity of this regimen.
Outcome measures
Outcome data not reported
Adverse Events
Bevacizumab
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab
n=6 participants at risk
Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.
Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m\^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.
Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m\^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.
5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.
Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays.
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Atrial flutter
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary arrest
|
16.7%
1/6 • Number of events 2
|
|
Investigations
Weight loss
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Wound complication, non-infectious
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Leak (including anastomotic), GI
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Necrosis, GI
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hematoma
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hemorrhage, GI
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Infection (Lung)
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Infection (Mediastinum)
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
16.7%
1/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Fistula, pulmonary/upper respiratory
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
16.7%
1/6 • Number of events 2
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
16.7%
1/6 • Number of events 1
|
Other adverse events
| Measure |
Bevacizumab
n=6 participants at risk
Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.
Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m\^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.
Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m\^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.
5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.
Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays.
|
|---|---|
|
Immune system disorders
Allergic Rhinitis
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
66.7%
4/6 • Number of events 11
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
16.7%
1/6 • Number of events 4
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
2/6 • Number of events 6
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
33.3%
2/6 • Number of events 2
|
|
Blood and lymphatic system disorders
Platelets
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Prolonged QTc interval
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
1/6 • Number of events 4
|
|
Cardiac disorders
Atrial flutter
|
33.3%
2/6 • Number of events 2
|
|
Cardiac disorders
Sinus bradycardia
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
2/6 • Number of events 2
|
|
Cardiac disorders
Ventricular arrhythmia
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary arrest, cause unknown (non-fatal)
|
16.7%
1/6 • Number of events 3
|
|
Cardiac disorders
Hypertension
|
16.7%
1/6 • Number of events 2
|
|
Cardiac disorders
Hypotension
|
33.3%
2/6 • Number of events 2
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
66.7%
4/6 • Number of events 6
|
|
General disorders
Fever (in the absence of neutropenia)
|
50.0%
3/6 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 2
|
|
General disorders
Rigors/chills
|
33.3%
2/6 • Number of events 2
|
|
Investigations
Weight loss
|
100.0%
6/6 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
33.3%
2/6 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Wound complication, non-infectious
|
16.7%
1/6 • Number of events 2
|
|
Gastrointestinal disorders
Anorexia
|
50.0%
3/6 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
Dehydration
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
83.3%
5/6 • Number of events 8
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
66.7%
4/6 • Number of events 9
|
|
Gastrointestinal disorders
Esophagitis
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
Fistula, GI
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel)
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Leak (including anastomotic), GI
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
66.7%
4/6 • Number of events 4
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
83.3%
5/6 • Number of events 11
|
|
Gastrointestinal disorders
Necrosis, GI
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
33.3%
2/6 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hematoma
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hemorrhage, GI
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hemorrhage, pulmonary/upper respiratory
|
33.3%
2/6 • Number of events 2
|
|
Infections and infestations
Colitis, infectious
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Infection (Lung)
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (Mediastinum)
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC (Mediastinum)
|
16.7%
1/6 • Number of events 3
|
|
Infections and infestations
Infection with normal ANC (Sinus)
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Infection with normal (Upper Aerodigestive)
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
16.7%
1/6 • Number of events 2
|
|
General disorders
Edema: limb
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
16.7%
1/6 • Number of events 6
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
33.3%
2/6 • Number of events 5
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
33.3%
2/6 • Number of events 6
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
33.3%
2/6 • Number of events 12
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
16.7%
1/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
33.3%
2/6 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
33.3%
2/6 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 2
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Mood alteration
|
50.0%
3/6 • Number of events 3
|
|
Nervous system disorders
Neuropathy: sensory
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Pain, Abdomen
|
50.0%
3/6 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain, Back
|
33.3%
2/6 • Number of events 3
|
|
Gastrointestinal disorders
Pain, Eosphagus
|
33.3%
2/6 • Number of events 3
|
|
Nervous system disorders
Pain, Head
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain, Joint
|
33.3%
2/6 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain, Muscle
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain, Neck
|
16.7%
1/6 • Number of events 2
|
|
Gastrointestinal disorders
Pain, Oral Cavity
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Pain, NOS
|
16.7%
1/6 • Number of events 2
|
|
Gastrointestinal disorders
Pain, Throat
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Pain - Other
|
16.7%
1/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Fistula, pulmonary/upper respiratory
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
33.3%
2/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
33.3%
2/6 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
50.0%
3/6 • Number of events 3
|
|
Vascular disorders
Vascular - Other
|
16.7%
1/6 • Number of events 1
|
Additional Information
Susan Urba, M.D.
University of Michigan Comprehensive Cancer Center
Phone: 734-615-4762
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place