Trial Outcomes & Findings for A Study of Amifostine (Ethyol) in Patients With Colorectal Cancer (NCT NCT00601198)
NCT ID: NCT00601198
Last Updated: 2023-08-01
Results Overview
There were only four participants in this study. None of which completed the questionnaires needed to assess this outcome. This study was closed by the sponsor on January 13, 2010 due to low enrollment.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
2 years
Results posted on
2023-08-01
Participant Flow
Participant milestones
| Measure |
Treatment Period
The chemotherapy regimen will be given for 2 consecutive days. On day #1, pt. will be premedicated with drugs to prevent nausea and vomiting in addition to intravenous fluids. Then they will receive amifostine intravenously followed by oxaliplatin, 5FU and leucovorin. This will be followed by an infusion of 5FU given in a pump over 22 hours. If the doctor decides on giving the pt. Avastin, this will be given on day #1. On day #2, they will receive the same treatment except for oxaliplatin.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Amifostine (Ethyol) in Patients With Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Treatment Period
n=4 Participants
The chemotherapy regimen will be given for 2 consecutive days. On day #1, pt. will be premedicated with drugs to prevent nausea and vomiting in addition to intravenous fluids. Then they will receive amifostine intravenously followed by oxaliplatin, 5FU and leucovorin. This will be followed by an infusion of 5FU given in a pump over 22 hours. If the doctor decides on giving the pt. Avastin, this will be given on day #1. On day #2, they will receive the same treatment except for oxaliplatin.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
50.83 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: There were only four participants in this study. None of which completed the questionnaires needed to assess this outcome. This study was closed by the sponsor on January 13, 2010 due to low enrollment.
There were only four participants in this study. None of which completed the questionnaires needed to assess this outcome. This study was closed by the sponsor on January 13, 2010 due to low enrollment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: There were only four participants in this study. None of which completed the questionnaires needed to assess this outcome. This study was closed by the sponsor on January 13, 2010 due to low enrollment.
There were only four participants in this study. None of which completed the questionnaires needed to assess this outcome. This study was closed by the sponsor on January 13, 2010 due to low enrollment.
Outcome measures
Outcome data not reported
Adverse Events
Treatment Period
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment Period
n=4 participants at risk
The chemotherapy regimen will be given for 2 consecutive days. On day #1, pt. will be premedicated with drugs to prevent nausea and vomiting in addition to intravenous fluids. Then they will receive amifostine intravenously followed by oxaliplatin, 5FU and leucovorin. This will be followed by an infusion of 5FU given in a pump over 22 hours. If the doctor decides on giving the pt. Avastin, this will be given on day #1. On day #2, they will receive the same treatment except for oxaliplatin.
|
|---|---|
|
Gastrointestinal disorders
Small bowel obstruction
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Leukocytosis
|
25.0%
1/4 • Number of events 1
|
Other adverse events
| Measure |
Treatment Period
n=4 participants at risk
The chemotherapy regimen will be given for 2 consecutive days. On day #1, pt. will be premedicated with drugs to prevent nausea and vomiting in addition to intravenous fluids. Then they will receive amifostine intravenously followed by oxaliplatin, 5FU and leucovorin. This will be followed by an infusion of 5FU given in a pump over 22 hours. If the doctor decides on giving the pt. Avastin, this will be given on day #1. On day #2, they will receive the same treatment except for oxaliplatin.
|
|---|---|
|
Eye disorders
Visual changes
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Abnormal pain
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 2
|
|
Gastrointestinal disorders
Gum problems
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis
|
50.0%
2/4 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2
|
|
Gastrointestinal disorders
Taste alteration
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Number of events 2
|
|
General disorders
Bone pain
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Edema limbs
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 1
|
|
Immune system disorders
Hand foot skin reaction
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
Oral thrush
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Albumin- low
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Alkaline phosphatase low
|
25.0%
1/4 • Number of events 1
|
|
Investigations
ANC - low
|
25.0%
1/4 • Number of events 1
|
|
Investigations
AST level
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Hemoglobin- low
|
25.0%
1/4 • Number of events 1
|
|
Investigations
INR-high
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Platelet - low
|
50.0%
2/4 • Number of events 4
|
|
Investigations
Sodium - low
|
50.0%
2/4 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Jaw problem
|
25.0%
1/4 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lumbar Pain
|
25.0%
1/4 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Hyperactivity
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Neuropathy
|
50.0%
2/4 • Number of events 2
|
|
Nervous system disorders
Tingling in lip
|
25.0%
1/4 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
25.0%
1/4 • Number of events 1
|
|
Vascular disorders
Flushing
|
25.0%
1/4 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
25.0%
1/4 • Number of events 1
|
|
Vascular disorders
Warmth
|
25.0%
1/4 • Number of events 1
|
Additional Information
Alison Kastl, Director of Clinical Trials
University of Cincinnati
Phone: 813-584-0436
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place