Trial Outcomes & Findings for Cetuximab, Paclitaxel, Carboplatin & Radiation for Esoph, Gastroesoph & Gastric Cancer (NCT NCT00439608)
NCT ID: NCT00439608
Last Updated: 2020-02-17
Results Overview
pathologic complete response rate at surgery
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
within 30 days of last treatment
Results posted on
2020-02-17
Participant Flow
60 patients were enrolled at multiple hospitals and medical clinics
Participant milestones
| Measure |
Treatment
Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
Patients received cetuximab, 400 mg/mg2 over 2 h on Day 1 then 250 mg/m2/week over 1 h, for 5 additional weeks. Patients also received paclitaxel, 50 mg/m2/week, over 1 h and carboplatin AUC (area under the curve) = 2/week, over 30 min, for 6 weeks. Cetuximab was administered first. Patients were then monitored for 1 h. Paclitaxel was then administered followed by carboplatin. Radiation was generally administered after chemotherapy. Dexamethasone 20 mg intravenously (IV), diphenhydramine 50 mg IV, and ranitidine 50 mg IV were given 30 min before treatment. Dosages of dexamethasone and diphenhydramine could be reduced in subsequent weeks if no hypersensitivity reactions were observed.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cetuximab, Paclitaxel, Carboplatin & Radiation for Esoph, Gastroesoph & Gastric Cancer
Baseline characteristics by cohort
| Measure |
Treatment
n=60 Participants
Cetuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
40 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 30 days of last treatmentpathologic complete response rate at surgery
Outcome measures
| Measure |
Treatment
n=57 Participants
Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
|
|---|---|
|
Reponse Rate at Time of Surgery by Tissue
|
40 participants
|
SECONDARY outcome
Timeframe: baseline, then during treatment, about 5 weeks through 30 days post treatment.Population: 60 patients were analyzed for toxicity but 57 for overall response.
CTCAE version 3: grade 2 and 3 rash. This is reported as it was the most common toxicity.
Outcome measures
| Measure |
Treatment
n=60 Participants
Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
|
|---|---|
|
Number of Participants With Grade 2 and/or 3 Rash in Patients With Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus, Gastroesophageal Junction, or Stomach.
|
37 participants
|
Adverse Events
Treatment
Serious events: 7 serious events
Other events: 60 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment
n=60 participants at risk
Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
|
|---|---|
|
Gastrointestinal disorders
esophagitis
|
1.7%
1/60 • Number of events 1 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
Blood and lymphatic system disorders
ANC
|
3.3%
2/60 • Number of events 2 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
Blood and lymphatic system disorders
anemia
|
1.7%
1/60 • Number of events 1 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
Investigations
hypersensitivity cetuximab
|
1.7%
1/60 • Number of events 1 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
Other adverse events
| Measure |
Treatment
n=60 participants at risk
Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
61.7%
37/60 • Number of events 37 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
Gastrointestinal disorders
esophagitis
|
50.0%
30/60 • Number of events 30 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
General disorders
dehydration
|
48.3%
29/60 • Number of events 29 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
General disorders
fatigue
|
35.0%
21/60 • Number of events 21 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
Metabolism and nutrition disorders
anorexia
|
25.0%
15/60 • Number of events 15 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
Metabolism and nutrition disorders
weight loss
|
16.7%
10/60 • Number of events 10 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
General disorders
nausea
|
15.0%
9/60 • Number of events 9 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
General disorders
vomiting
|
3.3%
2/60 • Number of events 2 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
Gastrointestinal disorders
diarrhea
|
5.0%
3/60 • Number of events 3 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
Gastrointestinal disorders
constipation
|
8.3%
5/60 • Number of events 5 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
Investigations
Hypersensitivity
|
15.0%
9/60 • Number of events 9 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
Infections and infestations
infection
|
11.7%
7/60 • Number of events 7 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
General disorders
fever
|
5.0%
3/60 • Number of events 3 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
Metabolism and nutrition disorders
hyponatremia
|
5.0%
3/60 • Number of events 3 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.0%
3/60 • Number of events 3 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
3/60 • Number of events 3 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
Blood and lymphatic system disorders
Neutropenia
|
48.3%
29/60 • Number of events 29 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
Blood and lymphatic system disorders
Thromobocytopenia
|
5.0%
3/60 • Number of events 3 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
|
Blood and lymphatic system disorders
anemia
|
25.0%
15/60 • Number of events 15 • For 30 days post end of treatment, approximately 6 months.
CTCAE v 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place