S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer
Study Details
Study Description
Brief Summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of esophageal cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with combination chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy and radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
Primary
- Determine the 2-year overall survival of patients with previously untreated, clinically unresectable, locally advanced squamous cell carcinoma or adenocarcinoma of the esophagus treated with cetuximab, cisplatin, irinotecan, and thoracic radiotherapy.
Secondary
-
Determine the toxicity profile of this regimen in these patients.
-
Determine the probability of objective response (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.
-
Determine the time to progression in patients with measurable disease treated with this regimen.
-
Correlate, preliminarily, gene expression (RNA) levels and germline polymorphisms of genes involved in DNA repair (e.g., ECRCC-1 and XRCC-1), drug metabolism (e.g., UGT1A1), and the epidermal growth factor receptor (EGFR) pathway (e.g., EGFR, interleukin-8, and vascular endothelial growth factor) with response, time to progression, overall survival, and toxicity in patients treated with this regimen. (This will not be completed as this study was closed due to poor accrual.)
OUTLINE: This is a multicenter study.
Patients receive cetuximab intravenous (IV) over 1-2 hours on days 1, 8, and 15. Patients also receive cisplatin IV and irinotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of course 3, patients undergo thoracic radiotherapy once daily 5 days a week for 5-6 weeks (total of 28 treatments).
After completion of study treatment, patients are followed at 4 weeks and then every 3-6 months for up to 5 years after study entry.
PROJECTED ACCRUAL: A total of 75-100 patients (75 with adenocarcinoma and 25 with squamous cell carcinoma) will be accrued for this study.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Treatment Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3. |
Biological: cetuximab
400mg/m^2 loading dose, intravenous (IV) over 120 min, day 1 of cycle 1 only. 250mg/m^2 maintenance dose, IV over 60 min, Days 8 & 15 of Cycle 1 and Days 1, 8, and 15 of subsequent cycles.
Other Names:
Drug: cisplatin
30mg/m^2, bolus intravenous (IV), on Days 1 & 8 of each cycle.
Other Names:
Drug: irinotecan hydrochloride
65mg/m^2, intravenous (IV) over 30 min, on Days 1 & 8 of each cycle.
Other Names:
Radiation: radiation therapy
The total dose to the prescription point will be 5,040 cGy given in 28 fractions. The patient will be treated with one fraction per day with all fields treated per day. 180 cGy will be delivered to the isocenter. The dose variation in the planning target volume (PTV) will be +7% and -5% of the prescription point dose.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Survival at 2 Years [0-2 years]
Measured from time of registration to date of death due to any cause, or last contact date
Secondary Outcome Measures
- Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug [Patients were assessed for adverse events after every two cycles of chemotherapy.]
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.
- Objective Response (Confirmed and Unconfined, Complete and Partial) [at week 16, then every 3 months until progression]
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.
- Progression Free Survival [0 - 5 years]
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.
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Histologically confirmed primary squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (≥ 20 cm from the incisors*) or the gastroesophageal junction (confined to ≤ 2 cm into the gastric cardia)
-
Disease confined to the esophagus or peri-esophageal soft tissue
-
T4, M0 disease
-
Surgically unresectable disease by esophageal endoscopic ultrasonography OR medically unresectable disease
NOTE: *Patients with primary disease < 26 cm from the incisors must undergo bronchoscopy AND have negative cytology within the past 4 weeks
-
Measurable or non-measurable disease by x-ray, CT scan and/or MRI, or physical examination within the past 4 weeks (for measurable disease) or within the past 6 weeks (for non-measurable disease)
-
Tumor specimens available
-
No recurrent disease
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
-
Absolute neutrophil count (ANC) ≥ 1,500/mm^3
-
White Blood Cell (WBC) count ≥ 3,000/mm^3
-
Platelet count ≥ 100,000/mm^3
-
Hemoglobin ≥ 10.0 g/dL
Hepatic
-
Albumin normal
-
Bilirubin normal
-
Alkaline phosphatase normal
-
Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 times upper limit of normal
Renal
- Creatinine clearance > 50 mL/min
Other
-
Not pregnant or nursing
-
Fertile patients must use effective contraception
-
No prior severe reaction to monoclonal antibodies
-
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for esophageal cancer
Endocrine therapy
- Not specified
Radiotherapy
-
No prior radiotherapy for esophageal cancer
-
No concurrent intensity modulated radiotherapy
-
No concurrent cobalt-60
Surgery
- No prior surgical resection or attempted surgical resection of esophageal cancer
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mobile Infirmary Medical Center | Mobile | Alabama | United States | 36652-2144 |
2 | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
3 | Alta Bates Comprehensive Cancer Center | Berkeley | California | United States | 94704 |
4 | Providence Saint Joseph Medical Center - Burbank | Burbank | California | United States | 91505 |
5 | Peninsula Medical Center | Burlingame | California | United States | 94010 |
6 | Eden Medical Center | Castro Valley | California | United States | 94546 |
7 | Marin Cancer Institute at Marin General Hospital | Greenbrae | California | United States | 94904 |
8 | Sutter Health - Western Division Cancer Research Group | Greenbrae | California | United States | 94904 |
9 | Saint Rose Hospital | Hayward | California | United States | 94545 |
10 | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | United States | 90089-9181 |
11 | Highland General Hospital | Oakland | California | United States | 94602 |
12 | Alta Bates Summit Medical Center - Summit Campus | Oakland | California | United States | 94609 |
13 | CCOP - Bay Area Tumor Institute | Oakland | California | United States | 94609 |
14 | Desert Regional Medical Center Comprehensive Cancer Center | Palm Springs | California | United States | 92262 |
15 | Valley Care Medical Center | Pleasanton | California | United States | 94588 |
16 | University of California Davis Cancer Center | Sacramento | California | United States | 95817 |
17 | California Pacific Medical Center - California Campus | San Francisco | California | United States | 94118 |
18 | Doctors Medical Center - San Pablo Campus | San Pablo | California | United States | 94806 |
19 | CCOP - Santa Rosa Memorial Hospital | Sana Rosa | California | United States | 95405 |
20 | Sutter Solano Medical Center | Vallejo | California | United States | 94589 |
21 | Poudre Valley Hospital | Fort Collins | Colorado | United States | 80524 |
22 | Watson Clinic, LLC | Lakeland | Florida | United States | 33804-5000 |
23 | Augusta Oncology Associates - Walton Way | Augusta | Georgia | United States | 30901 |
24 | Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | United States | 31403-3089 |
25 | Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Savannah | Georgia | United States | 31405 |
26 | St. Luke's Mountain States Tumor Institute - Boise | Boise | Idaho | United States | 83712 |
27 | Regional Cancer Center at Memorial Medical Center | Springfield | Illinois | United States | 62781-0001 |
28 | St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | United States | 46107 |
29 | Reid Hospital & Health Care Services, Incorporated | Richmond | Indiana | United States | 47374 |
30 | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | United States | 66720 |
31 | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | United States | 67801 |
32 | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | United States | 67042 |
33 | Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | United States | 66160-7357 |
34 | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | United States | 67068 |
35 | Southwest Medical Center | Liberal | Kansas | United States | 67901 |
36 | Cancer Center of Kansas, PA - Newton | Newton | Kansas | United States | 67114 |
37 | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | United States | 67357 |
38 | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | United States | 67124 |
39 | Cancer Center of Kansas, PA - Salina | Salina | Kansas | United States | 67042 |
40 | Tammy Walker Cancer Center at Salina Regional Health Center | Salina | Kansas | United States | 67401 |
41 | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | United States | 67152 |
42 | Associates in Womens Health, PA - North Review | Wichita | Kansas | United States | 67203 |
43 | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | United States | 67208 |
44 | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | United States | 67214 |
45 | CCOP - Wichita | Wichita | Kansas | United States | 67214 |
46 | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | United States | 67214 |
47 | Wesley Medical Center | Wichita | Kansas | United States | 67214 |
48 | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | United States | 67156 |
49 | Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky | United States | 40536-0293 |
50 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109-0942 |
51 | Battle Creek Health System Cancer Care Center | Battle Creek | Michigan | United States | 49017 |
52 | Mecosta County Medical Center | Big Rapids | Michigan | United States | 49307 |
53 | Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
54 | CCOP - Grand Rapids | Grand Rapids | Michigan | United States | 49503 |
55 | Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan | United States | 49503 |
56 | Spectrum Health Hospital - Butterworth Campus | Grand Rapids | Michigan | United States | 49503 |
57 | Metro Health Hospital | Grand Rapids | Michigan | United States | 49506 |
58 | Holland Community Hospital | Holland | Michigan | United States | 49423 |
59 | Hackley Hospital | Muskegon | Michigan | United States | 49442 |
60 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
61 | CCOP - Kansas City | Kansas City | Missouri | United States | 64131 |
62 | Saint Louis University Cancer Center | Saint Louis | Missouri | United States | 63110 |
63 | CCOP - Cancer Research for the Ozarks | Springfield | Missouri | United States | 65802 |
64 | St. John's Regional Health Center | Springfield | Missouri | United States | 65804 |
65 | Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | United States | 65807 |
66 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
67 | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | United States | 59101 |
68 | Northern Rockies Radiation Oncology Center | Billings | Montana | United States | 59101 |
69 | St. Vincent Healthcare Cancer Care Services | Billings | Montana | United States | 59101 |
70 | Billings Clinic - Downtown | Billings | Montana | United States | 59107-7000 |
71 | Bozeman Deaconess Cancer Center | Bozeman | Montana | United States | 59715 |
72 | St. James Healthcare Cancer Care | Butte | Montana | United States | 59701 |
73 | Great Falls Clinic - Main Facility | Great Falls | Montana | United States | 59405 |
74 | Great Falls | Montana | United States | 59405 | |
75 | St. Peter's Hospital | Helena | Montana | United States | 59601 |
76 | Glacier Oncology, PLLC | Kalispell | Montana | United States | 59901 |
77 | Kalispell Medical Oncology at KRMC | Kalispell | Montana | United States | 59901 |
78 | Kalispell Regional Medical Center | Kalispell | Montana | United States | 59901 |
79 | Community Medical Center | Missoula | Montana | United States | 59801 |
80 | Guardian Oncology and Center for Wellness | Missoula | Montana | United States | 59804 |
81 | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | United States | 59807-7877 |
82 | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | United States | 59807 |
83 | Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney | Nebraska | United States | 68848-1990 |
84 | Interlakes Oncology/Hematology PC | Rochester | New York | United States | 14623 |
85 | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | United States | 14642 |
86 | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | United States | 27534 |
87 | McDowell Cancer Center at Akron General Medical Center | Akron | Ohio | United States | 44307 |
88 | Grandview Hospital | Dayton | Ohio | United States | 45405 |
89 | Good Samaritan Hospital | Dayton | Ohio | United States | 45406 |
90 | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | United States | 45409 |
91 | Samaritan North Cancer Care Center | Dayton | Ohio | United States | 45415 |
92 | Veterans Affairs Medical Center - Dayton | Dayton | Ohio | United States | 45428 |
93 | CCOP - Dayton | Dayton | Ohio | United States | 45429 |
94 | Blanchard Valley Medical Associates | Findlay | Ohio | United States | 45840 |
95 | Charles F. Kettering Memorial Hospital | Kettering | Ohio | United States | 45429 |
96 | Middletown Regional Hospital | Middletown | Ohio | United States | 45044 |
97 | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | United States | 45373-1300 |
98 | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | United States | 45385 |
99 | Legacy Mount Hood Medical Center | Gresham | Oregon | United States | 97030 |
100 | Providence Milwaukie Hospital | Milwaukie | Oregon | United States | 97222 |
101 | Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | Portland | Oregon | United States | 97210 |
102 | Providence Cancer Center at Providence Portland Medical Center | Portland | Oregon | United States | 97213-2967 |
103 | CCOP - Columbia River Oncology Program | Portland | Oregon | United States | 97225 |
104 | Providence St. Vincent Medical Center | Portland | Oregon | United States | 97225 |
105 | Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland | Oregon | United States | 97227 |
106 | Northwest Cancer Specialists at Rose Quarter Cancer Center | Portland | Oregon | United States | 97227 |
107 | Oregon Health & Science University Cancer Institute | Portland | Oregon | United States | 97239-3098 |
108 | Salem Hospital Regional Cancer Care Services | Salem | Oregon | United States | 97309-5014 |
109 | Legacy Meridian Park Hospital | Tualatin | Oregon | United States | 97062 |
110 | Roper St. Francis Cancer Center at Roper Hospital | Charleston | South Carolina | United States | 29401 |
111 | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
112 | CCOP - Greenville | Greenville | South Carolina | United States | 29615 |
113 | Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport | Tennessee | United States | 37662 |
114 | U.T. Cancer Institute at University of Tennessee Medical Center | Knoxville | Tennessee | United States | 37920-6999 |
115 | Danville Regional Medical Center | Danville | Virginia | United States | 24541 |
116 | Southwest Virginia Regional Cancer Center | Norton | Virginia | United States | 24273 |
117 | St. Joseph Cancer Center | Bellingham | Washington | United States | 98225 |
118 | Olympic Hematology and Oncology | Bremerton | Washington | United States | 98310 |
119 | Columbia Basin Hematology | Kennewick | Washington | United States | 99336 |
120 | Skagit Valley Hospital Cancer Care Center | Mt. Vernon | Washington | United States | 98273 |
121 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98104 |
122 | Harborview Medical Center | Seattle | Washington | United States | 98104 |
123 | Minor and James Medical, PLLC | Seattle | Washington | United States | 98104 |
124 | Group Health Central Hospital | Seattle | Washington | United States | 98112 |
125 | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | United States | 98122-4307 |
126 | Polyclinic First Hill | Seattle | Washington | United States | 98122 |
127 | University Cancer Center at University of Washington Medical Center | Seattle | Washington | United States | 98195-6043 |
128 | Cancer Care Northwest - Spokane South | Spokane | Washington | United States | 99202 |
129 | Southwest Washington Medical Center Cancer Center | Vancouver | Washington | United States | 98668 |
130 | Northwest Cancer Specialists at Vancouver Cancer Center | Vancouver | Washington | United States | 98684 |
131 | Wenatchee Valley Medical Center | Wenatchee | Washington | United States | 98801-2028 |
132 | Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | United States | 82801 |
Sponsors and Collaborators
- Southwest Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Charles R. Thomas, MD, OHSU Knight Cancer Institute
- Study Chair: Charles D. Blanke, MD, FACP, OHSU Knight Cancer Institute
- Study Chair: James L. Abbruzzese, MD, M.D. Anderson Cancer Center
- Study Chair: Lisa Hammond, MD, The University of Texas Health Science Center at San Antonio
- Study Chair: Vivek Mehta, MD, Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000426442
- S0414
- U10CA032102
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Treatment |
---|---|
Arm/Group Description | Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3 |
Period Title: Overall Study | |
STARTED | 22 |
Eligible | 21 |
Eligible and Began Protocol Therapy | 21 |
COMPLETED | 18 |
NOT COMPLETED | 4 |
Baseline Characteristics
Arm/Group Title | Treatment |
---|---|
Arm/Group Description | Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3 |
Overall Participants | 21 |
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
61.4
|
Sex: Female, Male (Count of Participants) | |
Female |
6
28.6%
|
Male |
15
71.4%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
0
0%
|
Not Hispanic or Latino |
20
95.2%
|
Unknown or Not Reported |
1
4.8%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
2
9.5%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
4
19%
|
White |
15
71.4%
|
More than one race |
0
0%
|
Unknown or Not Reported |
0
0%
|
Outcome Measures
Title | Overall Survival at 2 Years |
---|---|
Description | Measured from time of registration to date of death due to any cause, or last contact date |
Time Frame | 0-2 years |
Outcome Measure Data
Analysis Population Description |
---|
All eligible patients who started treatment were included in the analysis. |
Arm/Group Title | Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy |
---|---|
Arm/Group Description | 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. |
Measure Participants | 21 |
Number (95% Confidence Interval) [percentage of participants] |
33.3
158.6%
|
Title | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug |
---|---|
Description | 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. |
Time Frame | Patients were assessed for adverse events after every two cycles of chemotherapy. |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy |
---|---|
Arm/Group Description | 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. |
Measure Participants | 21 |
Albumin, serum-low (hypoalbuminemia) |
1
4.8%
|
Anorexia |
4
19%
|
CNS cerebrovascular ischemia |
1
4.8%
|
Calcium, serum-low (hypocalcemia) |
1
4.8%
|
Creatinine |
1
4.8%
|
Death not associated w/CTCAE term - Sudden death |
1
4.8%
|
Dehydration |
4
19%
|
Dermatology/Skin-Other (Specify) |
1
4.8%
|
Diarrhea |
5
23.8%
|
Dysphagia (difficulty swallowing) |
3
14.3%
|
Esophagitis |
2
9.5%
|
Fatigue (asthenia, lethargy, malaise) |
5
23.8%
|
Febrile neutropenia |
1
4.8%
|
Glucose, serum-high (hyperglycemia) |
1
4.8%
|
Hemoglobin |
3
14.3%
|
Leukocytes (total WBC) |
9
42.9%
|
Lymphopenia |
4
19%
|
Magnesium, serum-low (hypomagnesemia) |
1
4.8%
|
Nausea |
4
19%
|
Necrosis, GI - Colon/cecum/appendix |
1
4.8%
|
Neuropathy: sensory |
1
4.8%
|
Neutrophils/granulocytes (ANC/AGC) |
6
28.6%
|
Pain - Abdomen NOS |
1
4.8%
|
Pain - Esophagus |
1
4.8%
|
Perforation, GI - Colon |
1
4.8%
|
Potassium, serum-low (hypokalemia) |
2
9.5%
|
Rash: acne/acneiform |
1
4.8%
|
Renal failure |
1
4.8%
|
Sodium, serum-low (hyponatremia) |
1
4.8%
|
Thrombosis/thrombus/embolism |
1
4.8%
|
Typhlitis (cecal inflammation) |
1
4.8%
|
Vomiting |
3
14.3%
|
Weight loss |
1
4.8%
|
Title | Objective Response (Confirmed and Unconfined, Complete and Partial) |
---|---|
Description | 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. |
Time Frame | at week 16, then every 3 months until progression |
Outcome Measure Data
Analysis Population Description |
---|
All eligible patients who started treatment and were evaluable for response were included in assessing response estimates. |
Arm/Group Title | Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy |
---|---|
Arm/Group Description | 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. |
Measure Participants | 17 |
Number (95% Confidence Interval) [percentage of participants] |
17.6
83.8%
|
Title | Progression Free Survival |
---|---|
Description | 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. |
Time Frame | 0 - 5 years |
Outcome Measure Data
Analysis Population Description |
---|
All eligible patients who started treatment were included in the analysis. |
Arm/Group Title | Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy |
---|---|
Arm/Group Description | 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. |
Measure Participants | 21 |
Median (95% Confidence Interval) [months] |
6.4
|
Adverse Events
Time Frame | Patients were assessed for adverse events after every two cycles of chemotherapy. | |
---|---|---|
Adverse Event Reporting Description | Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported. | |
Arm/Group Title | Cetuximab+Cisplatin+Irinotecan Followed by RT in Cycle 3 | |
Arm/Group Description | 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. | |
All Cause Mortality |
||
Cetuximab+Cisplatin+Irinotecan Followed by RT in Cycle 3 | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Cetuximab+Cisplatin+Irinotecan Followed by RT in Cycle 3 | ||
Affected / at Risk (%) | # Events | |
Total | 3/21 (14.3%) | |
Gastrointestinal disorders | ||
Necrosis, GI - Colon/cecum/appendix | 1/21 (4.8%) | |
General disorders | ||
Death not associated with CTCAE term - Sudden death | 1/21 (4.8%) | |
Nervous system disorders | ||
CNS cerebrovascular ischemia | 1/21 (4.8%) | |
Other (Not Including Serious) Adverse Events |
||
Cetuximab+Cisplatin+Irinotecan Followed by RT in Cycle 3 | ||
Affected / at Risk (%) | # Events | |
Total | 21/21 (100%) | |
Blood and lymphatic system disorders | ||
Hemoglobin | 10/21 (47.6%) | |
Gastrointestinal disorders | ||
Constipation | 9/21 (42.9%) | |
Diarrhea | 15/21 (71.4%) | |
Dysphagia (difficulty swallowing) | 8/21 (38.1%) | |
Esophagitis | 4/21 (19%) | |
Heartburn/dyspepsia | 2/21 (9.5%) | |
Mucositis/stomatitis (clinical exam) - Oral cavity | 4/21 (19%) | |
Mucositis/stomatitis (functional/symptomatic) - Oral cavity | 3/21 (14.3%) | |
Nausea | 19/21 (90.5%) | |
Pain - Abdomen NOS | 2/21 (9.5%) | |
Pain - Esophagus | 4/21 (19%) | |
Vomiting | 10/21 (47.6%) | |
General disorders | ||
Fatigue (asthenia, lethargy, malaise) | 16/21 (76.2%) | |
Injury, poisoning and procedural complications | ||
Rash: dermatitis associated with radiation - Chemoradiation | 2/21 (9.5%) | |
Investigations | ||
ALT, SGPT (serum glutamic pyruvic transaminase) | 2/21 (9.5%) | |
AST, SGOT (serum glutamic oxaloacetic transaminase) | 2/21 (9.5%) | |
Alkaline phosphatase | 4/21 (19%) | |
Leukocytes (total WBC) | 14/21 (66.7%) | |
Lymphopenia | 4/21 (19%) | |
Neutrophils/granulocytes (ANC/AGC) | 14/21 (66.7%) | |
Platelets | 8/21 (38.1%) | |
Weight loss | 10/21 (47.6%) | |
Metabolism and nutrition disorders | ||
Albumin, serum-low (hypoalbuminemia) | 5/21 (23.8%) | |
Anorexia | 8/21 (38.1%) | |
Calcium, serum-low (hypocalcemia) | 6/21 (28.6%) | |
Dehydration | 4/21 (19%) | |
Glucose, serum-high (hyperglycemia) | 6/21 (28.6%) | |
Magnesium, serum-low (hypomagnesemia) | 8/21 (38.1%) | |
Potassium, serum-low (hypokalemia) | 5/21 (23.8%) | |
Sodium, serum-low (hyponatremia) | 6/21 (28.6%) | |
Musculoskeletal and connective tissue disorders | ||
Pain - Muscle | 2/21 (9.5%) | |
Nervous system disorders | ||
Neuropathy: sensory | 2/21 (9.5%) | |
Taste alteration (dysgeusia) | 4/21 (19%) | |
Respiratory, thoracic and mediastinal disorders | ||
Cough | 2/21 (9.5%) | |
Skin and subcutaneous tissue disorders | ||
Dry skin | 7/21 (33.3%) | |
Hair loss/Alopecia (scalp or body) | 2/21 (9.5%) | |
Rash/desquamation | 2/21 (9.5%) | |
Rash: acne/acneiform | 13/21 (61.9%) | |
Vascular disorders | ||
Hypotension | 2/21 (9.5%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Study Statistician |
---|---|
Organization | SWOG Statistical Center |
Phone | 206-667-4623 |
- CDR0000426442
- S0414
- U10CA032102