Trial Outcomes & Findings for S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer (NCT NCT00109850)
NCT ID: NCT00109850
Last Updated: 2015-11-18
Results Overview
Measured from time of registration to date of death due to any cause, or last contact date
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
0-2 years
Results posted on
2015-11-18
Participant Flow
Participant milestones
| Measure |
Treatment
Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
Eligible
|
21
|
|
Overall Study
Eligible and Began Protocol Therapy
|
21
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Treatment
Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
2
|
|
Overall Study
Ineligible
|
1
|
Baseline Characteristics
S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer
Baseline characteristics by cohort
| Measure |
Treatment
n=21 Participants
Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3
|
|---|---|
|
Age, Continuous
|
61.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-2 yearsPopulation: All eligible patients who started treatment were included in the analysis.
Measured from time of registration to date of death due to any cause, or last contact date
Outcome measures
| Measure |
Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy
n=21 Participants
Patients received four 21-day cycles of cetuximab 400 mg/m\^2 (day 1, cycle 1), cetuximab 250 mg/m\^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m\^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m\^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
|
|---|---|
|
Overall Survival at 2 Years
|
33.3 percentage of participants
Interval 14.6 to 57.0
|
SECONDARY outcome
Timeframe: Patients were assessed for adverse events after every two cycles of chemotherapy.Population: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Outcome measures
| Measure |
Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy
n=21 Participants
Patients received four 21-day cycles of cetuximab 400 mg/m\^2 (day 1, cycle 1), cetuximab 250 mg/m\^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m\^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m\^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
|
|---|---|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Albumin, serum-low (hypoalbuminemia)
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Anorexia
|
4 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
CNS cerebrovascular ischemia
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Calcium, serum-low (hypocalcemia)
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Creatinine
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Death not associated w/CTCAE term - Sudden death
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dehydration
|
4 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dermatology/Skin-Other (Specify)
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Diarrhea
|
5 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dysphagia (difficulty swallowing)
|
3 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Esophagitis
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Fatigue (asthenia, lethargy, malaise)
|
5 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Febrile neutropenia
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Glucose, serum-high (hyperglycemia)
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hemoglobin
|
3 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Leukocytes (total WBC)
|
9 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Lymphopenia
|
4 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Magnesium, serum-low (hypomagnesemia)
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Nausea
|
4 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Necrosis, GI - Colon/cecum/appendix
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Neuropathy: sensory
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Neutrophils/granulocytes (ANC/AGC)
|
6 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Abdomen NOS
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Esophagus
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Perforation, GI - Colon
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Potassium, serum-low (hypokalemia)
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Rash: acne/acneiform
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Renal failure
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Sodium, serum-low (hyponatremia)
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Thrombosis/thrombus/embolism
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Typhlitis (cecal inflammation)
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Vomiting
|
3 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Weight loss
|
1 Participants
|
SECONDARY outcome
Timeframe: at week 16, then every 3 months until progressionPopulation: All eligible patients who started treatment and were evaluable for response were included in assessing response estimates.
Complete response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.
Outcome measures
| Measure |
Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy
n=17 Participants
Patients received four 21-day cycles of cetuximab 400 mg/m\^2 (day 1, cycle 1), cetuximab 250 mg/m\^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m\^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m\^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
|
|---|---|
|
Objective Response (Confirmed and Unconfined, Complete and Partial)
|
17.6 percentage of participants
Interval 3.8 to 43.4
|
SECONDARY outcome
Timeframe: 0 - 5 yearsPopulation: All eligible patients who started treatment were included in the analysis.
Measured from date of registration to date of first observation of progression or symptomatic deterioration. Patients last known to be alive and progression-free are censored at date of last contact.
Outcome measures
| Measure |
Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy
n=21 Participants
Patients received four 21-day cycles of cetuximab 400 mg/m\^2 (day 1, cycle 1), cetuximab 250 mg/m\^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m\^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m\^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
|
|---|---|
|
Progression Free Survival
|
6.4 months
Interval 3.7 to 12.0
|
Adverse Events
Cetuximab+Cisplatin+Irinotecan Followed by RT in Cycle 3
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab+Cisplatin+Irinotecan Followed by RT in Cycle 3
n=21 participants at risk
Patients received four 21-day cycles of cetuximab 400 mg/m\^2 (day 1, cycle 1), cetuximab 250 mg/m\^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m\^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m\^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
|
|---|---|
|
Gastrointestinal disorders
Necrosis, GI - Colon/cecum/appendix
|
4.8%
1/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Death not associated with CTCAE term - Sudden death
|
4.8%
1/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
4.8%
1/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
Other adverse events
| Measure |
Cetuximab+Cisplatin+Irinotecan Followed by RT in Cycle 3
n=21 participants at risk
Patients received four 21-day cycles of cetuximab 400 mg/m\^2 (day 1, cycle 1), cetuximab 250 mg/m\^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m\^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m\^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
47.6%
10/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Constipation
|
42.9%
9/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Diarrhea
|
71.4%
15/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
38.1%
8/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Esophagitis
|
19.0%
4/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
9.5%
2/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
19.0%
4/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Oral cavity
|
14.3%
3/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Nausea
|
90.5%
19/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
9.5%
2/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Pain - Esophagus
|
19.0%
4/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Vomiting
|
47.6%
10/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
76.2%
16/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated with radiation - Chemoradiation
|
9.5%
2/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
9.5%
2/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
9.5%
2/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Alkaline phosphatase
|
19.0%
4/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Leukocytes (total WBC)
|
66.7%
14/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Lymphopenia
|
19.0%
4/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
66.7%
14/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Platelets
|
38.1%
8/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Weight loss
|
47.6%
10/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
23.8%
5/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Anorexia
|
38.1%
8/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
28.6%
6/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
19.0%
4/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
28.6%
6/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
38.1%
8/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
23.8%
5/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
28.6%
6/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
9.5%
2/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Neuropathy: sensory
|
9.5%
2/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
19.0%
4/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
2/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
7/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
9.5%
2/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
9.5%
2/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
61.9%
13/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Vascular disorders
Hypotension
|
9.5%
2/21 • Patients were assessed for adverse events after every two cycles of chemotherapy.
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
Additional Information
Study Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place