Trial Outcomes & Findings for Cetuximab, Cisplatin, and Irinotecan in Treating Patients With Metastatic Esophageal Cancer, Gastroesophageal Junction Cancer, or Gastric Cancer That Did Not Respond to Previous Irinotecan and Cisplatin (NCT NCT00397904)
NCT ID: NCT00397904
Last Updated: 2015-11-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
2 years
Results posted on
2015-11-25
Participant Flow
Participant milestones
| Measure |
Cetuximab, Cisplatin, and Irinotecan
Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cetuximab, Cisplatin, and Irinotecan in Treating Patients With Metastatic Esophageal Cancer, Gastroesophageal Junction Cancer, or Gastric Cancer That Did Not Respond to Previous Irinotecan and Cisplatin
Baseline characteristics by cohort
| Measure |
Cetuximab, Cisplatin, and Irinotecan
n=16 Participants
Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Cetuximab, Cisplatin, and Irinotecan
n=16 Participants
Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
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|---|---|
|
Complete and Partial Response Rate
Complete Response
|
0 participants
|
|
Complete and Partial Response Rate
Partial Response
|
1 participants
|
|
Complete and Partial Response Rate
Stable Disease
|
4 participants
|
|
Complete and Partial Response Rate
Progression of Disease
|
11 participants
|
Adverse Events
Cetuximab, Cisplatin, and Irinotecan
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab, Cisplatin, and Irinotecan
n=16 participants at risk
Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
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|---|---|
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Investigations
Blood bilirubin increased
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Cardiac troponin I increased
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Sudden death NOS
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Death-Disease Progression NOS
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
2/16 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Platelet count decreased
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
1/16 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
12.5%
2/16 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1
|
Other adverse events
| Measure |
Cetuximab, Cisplatin, and Irinotecan
n=16 participants at risk
Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
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|---|---|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
37.5%
6/16 • Number of events 22
|
|
Investigations
Alkaline phosphatase increase
|
18.8%
3/16 • Number of events 10
|
|
Investigations
Cardiac troponin I increased
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
1/16 • Number of events 2
|
|
General disorders
Fatigue
|
37.5%
6/16 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
4/16 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
43.8%
7/16 • Number of events 34
|
|
Investigations
INR increased
|
12.5%
2/16 • Number of events 10
|
|
Investigations
White blood cell decreased
|
18.8%
3/16 • Number of events 5
|
|
Investigations
Lymphocyte count decreased
|
43.8%
7/16 • Number of events 13
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
37.5%
6/16 • Number of events 32
|
|
Investigations
Neutrophil count decreased
|
12.5%
2/16 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.2%
1/16 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
25.0%
4/16 • Number of events 8
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Weight loss
|
6.2%
1/16 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place