Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00079274 |
Recruitment Status :
Completed
First Posted : March 10, 2004
Results First Posted : February 9, 2015
Last Update Posted : May 13, 2020
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Adenocarcinoma of the Colon Stage III Colon Cancer |
Interventions |
Drug: irinotecan hydrochloride Drug: oxaliplatin Drug: leucovorin calcium Drug: fluorouracil Biological: cetuximab Drug: Locally Directed Therapy |
Enrollment | 3397 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Arm A (Combination Chemotherapy) | Arm B (Combination Chemotherapy) | Arm C (Combination Chemotherapy) | Arm D (Combination Chemotherapy, Monoclonal Antibody) | Arm E (Combination Chemotherapy, Monoclonal Antibody) | Arm F (Combination Chemotherapy, Monoclonal Antibody) | Arm G (Locally Directed Therapy) |
---|---|---|---|---|---|---|---|
![]() |
Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease. oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV |
Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease. irinotecan hydrochloride: Given IV leucovorin calcium: Given IV fluorouracil: Given IV |
Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease. irinotecan hydrochloride: Given IV oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV |
Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease. oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV cetuximab: Given IV |
Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease. irinotecan hydrochloride: Given IV leucovorin calcium: Given IV fluorouracil: Given I cetuximab: Given IV |
Patients received cetuximab as in arm D and chemotherapy as in arm C. irinotecan hydrochloride: Given IV oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV cetuximab: Given IV |
Patients determined to have mutated Kirsten rat sarcoma (KRAS) (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists. Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists. |
Period Title: Overall Study | |||||||
Started | 1402 | 111 | 111 | 1350 | 45 | 46 | 332 |
Completed | 1081 | 84 | 84 | 906 | 30 | 26 | 332 |
Not Completed | 321 | 27 | 27 | 444 | 15 | 20 | 0 |
Reason Not Completed | |||||||
Withdrawal by Subject | 111 | 10 | 12 | 163 | 7 | 8 | 0 |
Adverse Event | 130 | 8 | 8 | 184 | 7 | 8 | 0 |
Recurrence | 21 | 0 | 1 | 15 | 0 | 2 | 0 |
Alternate Treatment | 6 | 1 | 0 | 3 | 0 | 0 | 0 |
Other Medical Problems | 6 | 1 | 0 | 7 | 0 | 0 | 0 |
Death | 4 | 0 | 1 | 15 | 0 | 0 | 0 |
Cytogenetic resistance | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
Other | 43 | 7 | 5 | 55 | 1 | 2 | 0 |
Arm/Group Title | Arm A (Combination Chemotherapy) | Arm B (Combination Chemotherapy) | Arm C (Combination Chemotherapy) | Arm D (Combination Chemotherapy, Monoclonal Antibody) | Arm E (Combination Chemotherapy, Monoclonal Antibody) | Arm F (Combination Chemotherapy, Monoclonal Antibody) | Arm G (Locally Directed Therapy) | Total | |
---|---|---|---|---|---|---|---|---|---|
![]() |
Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease. oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV |
Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease. irinotecan hydrochloride: Given IV leucovorin calcium: Given IV fluorouracil: Given IV |
Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease. irinotecan hydrochloride: Given IV oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV |
Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease. oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV cetuximab: Given IV |
Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease. irinotecan hydrochloride: Given IV leucovorin calcium: Given IV fluorouracil: Given IV cetuximab: Given IV |
Patients received cetuximab as in arm D and chemotherapy as in arm C. irinotecan hydrochloride: Given IV oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV cetuximab: Given IV |
Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists. Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 1402 | 111 | 111 | 1350 | 45 | 46 | 332 | 3397 | |
![]() |
[Not Specified]
|
||||||||
Age, Continuous
Median (Full Range) Unit of measure: Years |
|||||||||
Number Analyzed | 1402 participants | 111 participants | 111 participants | 1350 participants | 45 participants | 46 participants | 332 participants | 3397 participants | |
58
(19 to 85)
|
57
(25 to 82)
|
60
(24 to 82)
|
58
(22 to 86)
|
59
(30 to 82)
|
60.5
(30 to 81)
|
56
(22 to 84)
|
58
(19 to 86)
|
||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||||||
Number Analyzed | 1402 participants | 111 participants | 111 participants | 1350 participants | 45 participants | 46 participants | 332 participants | 3397 participants | |
Female |
662 47.2%
|
53 47.7%
|
50 45.0%
|
647 47.9%
|
20 44.4%
|
21 45.7%
|
160 48.2%
|
1613 47.5%
|
|
Male |
740 52.8%
|
58 52.3%
|
61 55.0%
|
703 52.1%
|
25 55.6%
|
25 54.3%
|
172 51.8%
|
1784 52.5%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||||||
Number Analyzed | 1402 participants | 111 participants | 111 participants | 1350 participants | 45 participants | 46 participants | 332 participants | 3397 participants | |
Hispanic or Latino |
64 4.6%
|
5 4.5%
|
3 2.7%
|
62 4.6%
|
4 8.9%
|
2 4.3%
|
18 5.4%
|
158 4.7%
|
|
Not Hispanic or Latino |
1107 79.0%
|
103 92.8%
|
103 92.8%
|
1060 78.5%
|
38 84.4%
|
41 89.1%
|
225 67.8%
|
2677 78.8%
|
|
Unknown or Not Reported |
231 16.5%
|
3 2.7%
|
5 4.5%
|
228 16.9%
|
3 6.7%
|
3 6.5%
|
89 26.8%
|
562 16.5%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||||||
Number Analyzed | 1402 participants | 111 participants | 111 participants | 1350 participants | 45 participants | 46 participants | 332 participants | 3397 participants | |
American Indian or Alaska Native |
6 0.4%
|
1 0.9%
|
1 0.9%
|
7 0.5%
|
0 0.0%
|
0 0.0%
|
1 0.3%
|
16 0.5%
|
|
Asian |
66 4.7%
|
4 3.6%
|
2 1.8%
|
62 4.6%
|
3 6.7%
|
0 0.0%
|
12 3.6%
|
149 4.4%
|
|
Native Hawaiian or Other Pacific Islander |
8 0.6%
|
0 0.0%
|
1 0.9%
|
7 0.5%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
16 0.5%
|
|
Black or African American |
94 6.7%
|
6 5.4%
|
7 6.3%
|
96 7.1%
|
5 11.1%
|
2 4.3%
|
29 8.7%
|
239 7.0%
|
|
White |
1202 85.7%
|
98 88.3%
|
100 90.1%
|
1154 85.5%
|
37 82.2%
|
43 93.5%
|
275 82.8%
|
2909 85.6%
|
|
More than one race |
3 0.2%
|
2 1.8%
|
0 0.0%
|
3 0.2%
|
0 0.0%
|
0 0.0%
|
1 0.3%
|
9 0.3%
|
|
Unknown or Not Reported |
23 1.6%
|
0 0.0%
|
0 0.0%
|
21 1.6%
|
0 0.0%
|
1 2.2%
|
14 4.2%
|
59 1.7%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 1402 participants | 111 participants | 111 participants | 1350 participants | 45 participants | 46 participants | 332 participants | 3397 participants |
United States | 1258 | 109 | 109 | 1224 | 44 | 46 | 303 | 3093 | |
Canada | 138 | 2 | 2 | 124 | 1 | 0 | 28 | 295 | |
Jamaica | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | |
Puerto Rico | 5 | 0 | 0 | 2 | 0 | 0 | 1 | 8 | |
Positive Nodes
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 1402 participants | 111 participants | 111 participants | 1350 participants | 45 participants | 46 participants | 332 participants | 3397 participants |
1-3 | 816 | 71 | 70 | 790 | 29 | 28 | 203 | 2007 | |
4+ | 586 | 40 | 41 | 560 | 16 | 18 | 129 | 1390 | |
[1]
Measure Description: Number of positive nodes
|
|||||||||
Tumor Stage
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 1402 participants | 111 participants | 111 participants | 1350 participants | 45 participants | 46 participants | 332 participants | 3397 participants |
T1 or T2 | 198 | 18 | 14 | 213 | 5 | 5 | 56 | 509 | |
T3 | 1046 | 78 | 93 | 983 | 35 | 39 | 214 | 2488 | |
T4 | 158 | 15 | 4 | 153 | 4 | 2 | 62 | 398 | |
Not Availabe | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 2 | |
[1]
Measure Description:
T1: Tumor invades submucosa T2: Tumor invades muscularis propria T3: Tumor invades through the muscularis propria into the subserosa or into non-peritonealized pericolic or perirectal tissues T4: (T4a+) Tumor perforates the visceral peritoneum without adherence to or invasion of other organs or structures or (T4b) Tumor is adherent to or directly invades other organs or structures |
|||||||||
Histologic Grade
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 1402 participants | 111 participants | 111 participants | 1350 participants | 45 participants | 46 participants | 332 participants | 3397 participants |
High | 357 | 25 | 28 | 345 | 10 | 12 | 60 | 837 | |
Low | 1045 | 86 | 83 | 1005 | 35 | 34 | 272 | 2560 | |
[1]
Measure Description: High=poorly differentiated or undifferentiated> Low=well or moderately differentiated
|
|||||||||
KRAS Status
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 1402 participants | 111 participants | 111 participants | 1350 participants | 45 participants | 46 participants | 332 participants | 3397 participants |
Unknown | 56 | 6 | 6 | 51 | 3 | 4 | 6 | 132 | |
Mutant | 391 | 33 | 43 | 345 | 15 | 13 | 326 | 1166 | |
Wildtype | 955 | 72 | 62 | 954 | 27 | 29 | 0 | 2099 |