Trial Outcomes & Findings for Study of Oxaliplatin and Xeloda and Cetuximab as First Line Treatment for Metastatic or Unresectable Gastric or Gastroesophageal Junction Cancer (NCT NCT00183898)
NCT ID: NCT00183898
Last Updated: 2026-07-30
Results Overview
Progression-free survival will be measured from the start of treatment until the time the patient is first recorded as having disease progression, or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last visit for tumor measurement.
COMPLETED
PHASE2
75 participants
every 2 cycles (6 weeks), up to 4 months.
2026-07-30
Participant Flow
Recruitment for this study opened in December 2004 and closed in January 2012. All subjects were seen and treated in the medical clinics at the University of Southern California, Los Angeles General Medical Center, and Los Angeles Clinic and Research Institute.
Participant milestones
| Measure |
Oxaliplatin and Capecitabine
Oxaliplatin given every 21 days Capecitabine given daily x 14 days every 21 days
oxaliplatin, capecitabine: cetuximab 400 mg/m2, followed by weekly cetuximab 250 mg/m2 with oxaliplatin 130 mg/m2 on day 1 (every 3 weeks) with capecitabine 850 mg/m2 bid, daily on days 1-14, every 3 weeks.
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
61
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Oxaliplatin and Capecitabine
Oxaliplatin given every 21 days Capecitabine given daily x 14 days every 21 days
oxaliplatin, capecitabine: cetuximab 400 mg/m2, followed by weekly cetuximab 250 mg/m2 with oxaliplatin 130 mg/m2 on day 1 (every 3 weeks) with capecitabine 850 mg/m2 bid, daily on days 1-14, every 3 weeks.
|
|---|---|
|
Overall Study
Disease progression
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
complication of disease
|
1
|
|
Overall Study
Began another treatment
|
1
|
Baseline Characteristics
Study of Oxaliplatin and Xeloda and Cetuximab as First Line Treatment for Metastatic or Unresectable Gastric or Gastroesophageal Junction Cancer
Baseline characteristics by cohort
| Measure |
Oxaliplatin and Capecitabine
n=61 Participants
Oxaliplatin given every 21 days Capecitabine given daily x 14 days every 21 days
oxaliplatin, capecitabine: cetuximab 400 mg/m2, followed by weekly cetuximab 250 mg/m2 with oxaliplatin 130 mg/m2 on day 1 (every 3 weeks) with capecitabine 850 mg/m2 bid, daily on days 1-14, every 3 weeks.
|
|---|---|
|
Age, Continuous
|
56 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=20 Participants
|
|
Karnofsky performance status %
100%
|
1 Participants
n=20 Participants
|
|
Karnofsky performance status %
90%
|
28 Participants
n=20 Participants
|
|
Karnofsky performance status %
80%
|
28 Participants
n=20 Participants
|
|
Karnofsky performance status %
70%
|
3 Participants
n=20 Participants
|
|
Karnofsky performance status %
Missing
|
1 Participants
n=20 Participants
|
|
Site of primary tumor
GE Junction
|
2 Participants
n=20 Participants
|
|
Site of primary tumor
Stomach
|
59 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: every 2 cycles (6 weeks), up to 4 months.Population: This includes all evaluable patients who received at least 2 cycles (6 weeks) of study treatment, had adequate information about tumor burden at baseline, had adequate tumor assessment information post-baseline, and received at least 50% of the anticipated treatment during the first 6 weeks.
Progression-free survival will be measured from the start of treatment until the time the patient is first recorded as having disease progression, or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last visit for tumor measurement.
Outcome measures
| Measure |
Oxaliplatin and Capecitabine
n=61 Participants
Oxaliplatin given every 21 days Capecitabine given daily x 14 days every 21 days
oxaliplatin, capecitabine: cetuximab 400 mg/m2, followed by weekly cetuximab 250 mg/m2 with oxaliplatin 130 mg/m2 on day 1 (every 3 weeks) with capecitabine 850 mg/m2 bid, daily on days 1-14, every 3 weeks.
|
|---|---|
|
Rate of Progression-Free Survival (PFS) at Month 4
|
61 percentage of participants
Interval 47.0 to 73.0
|
SECONDARY outcome
Timeframe: every 2 cycles (6 weeks), through study completion up to 2 years, 7 monthsPopulation: This includes all evaluable patients who received at least 2 cycles (6 weeks) of study treatment, had adequate information about tumor burden at baseline, had adequate tumor assessment information post-baseline, and received at least 50% of the anticipated treatment during the first 6 weeks.
The overall time to progression in patients with advanced gastric or gastroesophageal junction cancer treated with a combination of capecitabine and oxaliplatin. This differs from 4 months PFS rate outcome data, which assesses the progression-free survival at 4 months.
Outcome measures
| Measure |
Oxaliplatin and Capecitabine
n=61 Participants
Oxaliplatin given every 21 days Capecitabine given daily x 14 days every 21 days
oxaliplatin, capecitabine: cetuximab 400 mg/m2, followed by weekly cetuximab 250 mg/m2 with oxaliplatin 130 mg/m2 on day 1 (every 3 weeks) with capecitabine 850 mg/m2 bid, daily on days 1-14, every 3 weeks.
|
|---|---|
|
Time to Progression
|
5.4 Months
Interval 3.5 to 7.3
|
SECONDARY outcome
Timeframe: About 2 years, 7 monthsPopulation: This includes all evaluable patients who received at least 2 cycles (6 weeks) of study treatment, had adequate information about tumor burden at baseline, had adequate tumor assessment information post-baseline, and received at least 50% of the anticipated treatment during the first 6 weeks. 1 participant was excluded from the toxicity analysis due to missing report.
Outcome measures
| Measure |
Oxaliplatin and Capecitabine
n=60 Participants
Oxaliplatin given every 21 days Capecitabine given daily x 14 days every 21 days
oxaliplatin, capecitabine: cetuximab 400 mg/m2, followed by weekly cetuximab 250 mg/m2 with oxaliplatin 130 mg/m2 on day 1 (every 3 weeks) with capecitabine 850 mg/m2 bid, daily on days 1-14, every 3 weeks.
|
|---|---|
|
Number of Participants Who Experienced Toxicities During the Study Drug Regimen
|
39 Participants
|
SECONDARY outcome
Timeframe: Every 2 cycles (6 weeks), through study completion, up to 2 years, 7 monthsPopulation: This includes all evaluable patients who received at least 2 cycles (6 weeks) of study treatment, had adequate information about tumor burden at baseline, had adequate tumor assessment information post-baseline, and received at least 50% of the anticipated treatment during the first 6 weeks. 7 patients of the 61 patients, were inevaluable.
To determine overall response rate in patients with advanced gastric or gastroesophageal junction cancer treated with a combination of capecitabine and oxaliplatin
Outcome measures
| Measure |
Oxaliplatin and Capecitabine
n=54 Participants
Oxaliplatin given every 21 days Capecitabine given daily x 14 days every 21 days
oxaliplatin, capecitabine: cetuximab 400 mg/m2, followed by weekly cetuximab 250 mg/m2 with oxaliplatin 130 mg/m2 on day 1 (every 3 weeks) with capecitabine 850 mg/m2 bid, daily on days 1-14, every 3 weeks.
|
|---|---|
|
Overall Response Rate
Complete response
|
1 Participants
|
|
Overall Response Rate
Partial response
|
26 Participants
|
|
Overall Response Rate
Stable disease
|
22 Participants
|
|
Overall Response Rate
Progressive disease
|
5 Participants
|
SECONDARY outcome
Timeframe: Every 2 cycles (6 weeks), through study completion, up to 2 years, 7 monthsPopulation: This includes all evaluable patients who received at least 2 cycles (6 weeks) of study treatment, had adequate information about tumor burden at baseline, had adequate tumor assessment information post-baseline, and received at least 50% of the anticipated treatment during the first 6 weeks.
To determine overall survival in patients with advanced gastric or gastroesophageal junction cancer treated with a combination of capecitabine and oxaliplatin
Outcome measures
| Measure |
Oxaliplatin and Capecitabine
n=61 Participants
Oxaliplatin given every 21 days Capecitabine given daily x 14 days every 21 days
oxaliplatin, capecitabine: cetuximab 400 mg/m2, followed by weekly cetuximab 250 mg/m2 with oxaliplatin 130 mg/m2 on day 1 (every 3 weeks) with capecitabine 850 mg/m2 bid, daily on days 1-14, every 3 weeks.
|
|---|---|
|
Overall Survival
|
12.8 Months
Interval 8.7 to 19.4
|
SECONDARY outcome
Timeframe: Every 2 cycles (6 weeks), through study completion, up to 2 years, 7 monthsPopulation: This includes all evaluable patients who received at least 2 cycles (6 weeks) of study treatment, had adequate information about tumor burden at baseline, had adequate tumor assessment information post-baseline, and received at least 50% of the anticipated treatment during the first 6 weeks.
Progression-free survival (PFS), Median (95%CI), months
Outcome measures
| Measure |
Oxaliplatin and Capecitabine
n=61 Participants
Oxaliplatin given every 21 days Capecitabine given daily x 14 days every 21 days
oxaliplatin, capecitabine: cetuximab 400 mg/m2, followed by weekly cetuximab 250 mg/m2 with oxaliplatin 130 mg/m2 on day 1 (every 3 weeks) with capecitabine 850 mg/m2 bid, daily on days 1-14, every 3 weeks.
|
|---|---|
|
Progression-free Survival (PFS)
|
5.4 Months
Interval 3.5 to 7.3
|
Adverse Events
Oxaliplatin and Capecitabine
Serious adverse events
| Measure |
Oxaliplatin and Capecitabine
n=75 participants at risk
Oxaliplatin given every 21 days Capecitabine given daily x 14 days every 21 days
oxaliplatin, capecitabine: cetuximab 400 mg/m2, followed by weekly cetuximab 250 mg/m2 with oxaliplatin 130 mg/m2 on day 1 (every 3 weeks) with capecitabine 850 mg/m2 bid, daily on days 1-14, every 3 weeks.
|
|---|---|
|
Gastrointestinal disorders
Anorexia
|
10.7%
8/75 • About 2 years, 7 months
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/75 • About 2 years, 7 months
|
|
Gastrointestinal disorders
Dehydration
|
1.3%
1/75 • About 2 years, 7 months
|
|
Gastrointestinal disorders
Diarrhea
|
10.7%
8/75 • About 2 years, 7 months
|
|
Gastrointestinal disorders
Nausea
|
12.0%
9/75 • About 2 years, 7 months
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
9/75 • About 2 years, 7 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
10.7%
8/75 • About 2 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
2.7%
2/75 • About 2 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
2.7%
2/75 • About 2 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
6.7%
5/75 • About 2 years, 7 months
|
|
Nervous system disorders
Neuropathy: sensory
|
10.7%
8/75 • About 2 years, 7 months
|
|
Metabolism and nutrition disorders
hypocalcemia
|
1.3%
1/75 • About 2 years, 7 months
|
|
Metabolism and nutrition disorders
hypokalemia
|
2.7%
2/75 • About 2 years, 7 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
4.0%
3/75 • About 2 years, 7 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
6.7%
5/75 • About 2 years, 7 months
|
|
Blood and lymphatic system disorders
Platelets
|
1.3%
1/75 • About 2 years, 7 months
|
|
Hepatobiliary disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
1.3%
1/75 • About 2 years, 7 months
|
|
Hepatobiliary disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
1.3%
1/75 • About 2 years, 7 months
|
|
Gastrointestinal disorders
Hemorrhage, GI (Stomach)
|
1.3%
1/75 • About 2 years, 7 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Abdomen NOS)
|
1.3%
1/75 • About 2 years, 7 months
|
|
Gastrointestinal disorders
Pain (Abdomen NOS)
|
4.0%
3/75 • About 2 years, 7 months
|
Other adverse events
| Measure |
Oxaliplatin and Capecitabine
n=75 participants at risk
Oxaliplatin given every 21 days Capecitabine given daily x 14 days every 21 days
oxaliplatin, capecitabine: cetuximab 400 mg/m2, followed by weekly cetuximab 250 mg/m2 with oxaliplatin 130 mg/m2 on day 1 (every 3 weeks) with capecitabine 850 mg/m2 bid, daily on days 1-14, every 3 weeks.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
50.7%
38/75 • About 2 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
14.7%
11/75 • About 2 years, 7 months
|
|
Nervous system disorders
Dizziness
|
1.3%
1/75 • About 2 years, 7 months
|
|
Nervous system disorders
Neuropathy: sensory
|
14.7%
11/75 • About 2 years, 7 months
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
1.3%
1/75 • About 2 years, 7 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
4.0%
3/75 • About 2 years, 7 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
1.3%
1/75 • About 2 years, 7 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
8.0%
6/75 • About 2 years, 7 months
|
|
Blood and lymphatic system disorders
Platelets
|
4.0%
3/75 • About 2 years, 7 months
|
|
Hepatobiliary disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
6.7%
5/75 • About 2 years, 7 months
|
|
Hepatobiliary disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
6.7%
5/75 • About 2 years, 7 months
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
4.0%
3/75 • About 2 years, 7 months
|
|
Vascular disorders
Hypotension
|
1.3%
1/75 • About 2 years, 7 months
|
|
Eye disorders
Ocular/Visual - Other (Specify, __)
|
2.7%
2/75 • About 2 years, 7 months
|
|
Gastrointestinal disorders
Pain (Abdomen NOS)
|
6.7%
5/75 • About 2 years, 7 months
|
|
Gastrointestinal disorders
Anorexia
|
13.3%
10/75 • About 2 years, 7 months
|
|
Gastrointestinal disorders
Constipation
|
5.3%
4/75 • About 2 years, 7 months
|
|
Gastrointestinal disorders
Dehydration
|
1.3%
1/75 • About 2 years, 7 months
|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
2/75 • About 2 years, 7 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) (Oral cavity
|
8.0%
6/75 • About 2 years, 7 months
|
|
Gastrointestinal disorders
Nausea
|
13.3%
10/75 • About 2 years, 7 months
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
9/75 • About 2 years, 7 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
20.0%
15/75 • About 2 years, 7 months
|
|
General disorders
Weight loss
|
1.3%
1/75 • About 2 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Flushing
|
1.3%
1/75 • About 2 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
10.7%
8/75 • About 2 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
2.7%
2/75 • About 2 years, 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place