Trial Outcomes & Findings for Phase I/II Study of Panitumumab, Capecitabine and Oxaliplatin w EBRT for Esophageal Cancer (NCT NCT00578071)
NCT ID: NCT00578071
Last Updated: 2015-07-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
29 participants
Primary outcome timeframe
60 days
Results posted on
2015-07-02
Participant Flow
Participant milestones
| Measure |
Chemoradiation
Panitumumab, oxiplatin, capecitabine, radiation therapy
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I/II Study of Panitumumab, Capecitabine and Oxaliplatin w EBRT for Esophageal Cancer
Baseline characteristics by cohort
| Measure |
Chemoradiation
n=29 Participants
Panitumumab, oxiplatin, capecitabine, radiation therapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
|
Age, Continuous
|
58.97 years
STANDARD_DEVIATION 10.32 • n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: Per protocol and intention to treat (ITT).
Outcome measures
| Measure |
Chemoradiation
n=29 Participants
Panitumumab, oxiplatin, capecitabine, radiation therapy
|
|---|---|
|
Panitumumab Maximum Tolerated Dose in Milligrams (mg)
|
3.6 mg
|
PRIMARY outcome
Timeframe: Within 30 days of the last day of radiationPopulation: All patients who received chemoradiation.
Outcome measures
| Measure |
Chemoradiation
n=29 Participants
Panitumumab, oxiplatin, capecitabine, radiation therapy
|
|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLTs)
|
2 participants
|
SECONDARY outcome
Timeframe: One yearNumber of patients alive one year after completing study protocol treatment.
Outcome measures
| Measure |
Chemoradiation
n=29 Participants
Panitumumab, oxiplatin, capecitabine, radiation therapy
|
|---|---|
|
Overall Survival Rates for the Patients Studied on This Protocol.
|
18 participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Surgery was determined according to risk factors, patient consent and resectability.
Absence of residual viable tumor cells at the time of surgical resection of the esophagus performed 7-9 weeks following completion of chemoradiotherapy.
Outcome measures
| Measure |
Chemoradiation
n=20 Participants
Panitumumab, oxiplatin, capecitabine, radiation therapy
|
|---|---|
|
Pathological Complete Response Rates Associated With This Regimen.
|
40 percentage of participants
|
Adverse Events
Chemoradiation
Serious events: 9 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemoradiation
n=29 participants at risk
Panitumumab, oxiplatin, capecitabine, radiation therapy
|
|---|---|
|
Cardiac disorders
Atrial Fibrilation
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
10.3%
3/29 • Number of events 3
|
|
Infections and infestations
Febrile neutropenia
|
6.9%
2/29 • Number of events 2
|
|
Immune system disorders
Hypersensitivity reaction
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
6.9%
2/29 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
2/29 • Number of events 2
|
Other adverse events
| Measure |
Chemoradiation
n=29 participants at risk
Panitumumab, oxiplatin, capecitabine, radiation therapy
|
|---|---|
|
Gastrointestinal disorders
Anorexia
|
41.4%
12/29 • Number of events 12
|
|
Gastrointestinal disorders
Constipation
|
24.1%
7/29 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.3%
3/29 • Number of events 3
|
|
General disorders
Dehydration
|
34.5%
10/29 • Number of events 10
|
|
Gastrointestinal disorders
Diarrhea
|
27.6%
8/29 • Number of events 8
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
31.0%
9/29 • Number of events 9
|
|
General disorders
Edema: Limb
|
10.3%
3/29 • Number of events 3
|
|
Gastrointestinal disorders
Esophagitis
|
37.9%
11/29 • Number of events 11
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
65.5%
19/29 • Number of events 19
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.9%
2/29 • Number of events 2
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
24.1%
7/29 • Number of events 7
|
|
Gastrointestinal disorders
Hiccoughs
|
10.3%
3/29 • Number of events 3
|
|
Infections and infestations
Infection
|
24.1%
7/29 • Number of events 7
|
|
Metabolism and nutrition disorders
Potassium, serum-low
|
10.3%
3/29 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
69.0%
20/29 • Number of events 20
|
|
Nervous system disorders
Neuropathy: sensory
|
44.8%
13/29 • Number of events 13
|
|
Nervous system disorders
Pain
|
37.9%
11/29 • Number of events 11
|
|
Blood and lymphatic system disorders
Platelets
|
10.3%
3/29 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
93.1%
27/29 • Number of events 27
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
6.9%
2/29 • Number of events 2
|
|
Vascular disorders
Thrombosis, thrombus, embolism
|
6.9%
2/29 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
55.2%
16/29 • Number of events 16
|
|
General disorders
Weight Loss
|
17.2%
5/29 • Number of events 5
|
Additional Information
Dr Brian Czito
Duke University Medical Center Radiation Oncology
Phone: 668-7336
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place