Trial Outcomes & Findings for Study of XELOX With Cetuximab in Advanced Gastric Cancer (NCT NCT00398398)
NCT ID: NCT00398398
Last Updated: 2020-01-07
Results Overview
Tumor response was evaluated every two cycles by CT scans and other indicated methods, and the patients with complete or partial response required a confirmatory response evaluation at least 4 weeks later. Patients without confirmatory evaluation were not regarded as responders.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
6 months
Results posted on
2020-01-07
Participant Flow
Participant milestones
| Measure |
Xelox Plus Cetuximab
Capecitabine, oxaliplatin and cetuximab
cetuximab : initial loading dose of 400 mg/m2, maintenance dose of 250 mg/m2 (every week) Oxaliplatin : 130 mg/m2 (every 3 weeks) capecitabine :1,000 mg/m2 (days 1-14)
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of XELOX With Cetuximab in Advanced Gastric Cancer
Baseline characteristics by cohort
| Measure |
Xelox Plus Cetuximab
n=44 Participants
Capecitabine, oxaliplatin and cetuximab
|
|---|---|
|
Age, Customized
|
57.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsTumor response was evaluated every two cycles by CT scans and other indicated methods, and the patients with complete or partial response required a confirmatory response evaluation at least 4 weeks later. Patients without confirmatory evaluation were not regarded as responders.
Outcome measures
| Measure |
Xelox Plus Cetuximab
n=44 Participants
Capecitabine, oxaliplatin and cetuximab
|
|---|---|
|
Overall Response Rate
|
23 participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Xelox Plus Cetuximab
n=44 Participants
Capecitabine, oxaliplatin and cetuximab
|
|---|---|
|
Progression-free Survival
|
6.5 months
Interval 4.9 to 8.4
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Xelox Plus Cetuximab
n=44 Participants
Capecitabine, oxaliplatin and cetuximab
|
|---|---|
|
Overall Survival
|
11.8 months
Interval 6.7 to 16.8
|
SECONDARY outcome
Timeframe: 1 yearsNumber of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of XELOX plus Cetuximab
Outcome measures
| Measure |
Xelox Plus Cetuximab
n=44 Participants
Capecitabine, oxaliplatin and cetuximab
|
|---|---|
|
Toxicity Profile
|
44 participants
|
Adverse Events
Xelox Plus Cetuximab
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Xelox Plus Cetuximab
n=44 participants at risk
Capecitabine, oxaliplatin and cetuximab
|
|---|---|
|
Psychiatric disorders
Mood disorder
|
2.3%
1/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
Other adverse events
| Measure |
Xelox Plus Cetuximab
n=44 participants at risk
Capecitabine, oxaliplatin and cetuximab
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
81.8%
36/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
|
Blood and lymphatic system disorders
Leukopenia
|
20.5%
9/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.7%
10/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
45.5%
20/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
|
General disorders
Asthenia
|
81.8%
36/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
|
Gastrointestinal disorders
Anorexia
|
79.5%
35/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
22/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
|
Gastrointestinal disorders
Vomiting
|
29.5%
13/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
|
Gastrointestinal disorders
Stomatitis
|
63.6%
28/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
|
Gastrointestinal disorders
Diarrhea
|
52.3%
23/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
|
Nervous system disorders
Sensory neuropathy
|
75.0%
33/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
|
Skin and subcutaneous tissue disorders
Hand-foot syndrome
|
77.3%
34/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
|
Skin and subcutaneous tissue disorders
Acneiform rash
|
77.3%
34/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.7%
10/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
|
Hepatobiliary disorders
Elevated Aspartate aminotransferase
|
52.3%
23/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
|
Hepatobiliary disorders
Elevated alanine transferase
|
36.4%
16/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
|
Hepatobiliary disorders
Elevated bilirubin
|
22.7%
10/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
|
Immune system disorders
Infusion reaction
|
6.8%
3/44 • 1 year after completion of study treatment. If patients received another treatment, toxicity assessment was not done further.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place