Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079274
Status:
COMPLETED
Last Update Posted:
2020-05-13
First Post:
2004-03-08
Brief Title:
Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Trial of Oxaliplatin OXAL Plus 5-Fluorouracil 5-FULeucovorin CF With or Without Cetuximab C225 After Curative Resection for Patients With Stage III Colon Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work As of September 1 2004 the study was expanded to a total of 6 arms the original 3 arms A B C and 3 additional arms which were the same as the first 3 but with cetuximab in treating patients who have undergone surgery for stage III colon cancer Drugs used in chemotherapy such as irinotecan hydrochloride fluorouracil leucovorin calcium and oxaliplatin work in different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining more than one chemotherapy drug with monoclonal antibody therapy and giving them after surgery may kill any remaining tumor cells It was not known at the time this study was developed which combination chemotherapy regimen is more effective after surgery in treating colon cancer This study had several key changes based on the results of other phase III trials As of 612005 patients no longer received irinotecan on this study and treatment arms B C E and F were discontinued Patients on arms B and C crossed to arm A Patients on arms E and F crossed to arm D Patients on arms C and F who had not gotten to irinotecan continued on arms A and D respectively As of 8182008 pre-screening for Kirsten rat sarcoma KRAS status was added with mutant KRAS or KRAS not evaluable patients put on arm G and wild-type KRAS patients randomized between arm A and arm D Patients on arm G were treated per physician discretion and followed for disease and survival status KRAS was determined in a central laboratory and was process for all patients on this study The primary endpoint of this study was modified on 8182008 to focus on patients having wild-type KRAS tumors All modifications were approved by the Central Institution Review Board local Institutional Review Boards NCI and the NCCTG Data Safety Monitoring Board
Detailed Description:
PRIMARY OBJECTIVES
I Disease-free Survival Arms A and D Wild-type KRAS Patients
SECONDARY OBJECTIVES
I Disease-free Survival Arms A and D Mutant KRAS Patients II Disease-free Survival III Overall Survival IV Toxicity
OUTLINE This is a randomized multicenter study Patients are stratified according to positive lymph node involvement 1-3 vs 4 or more histology high poorly differentiated or undifferentiated vs low well to moderately differentiated and clinical T stage T1 or T2 vs T3 vs T4 Patients are randomized to 1 of 6 treatment arms as of 612005 patients are randomized to treatment arms I and IV only arms II III V and VI are closed to accrual As of 8182008 pre-screening for KRAS status was added with mutant KRAS or KRAS not evaluable patients put on arm G and wild-type KRAS patients randomized between arm A and arm D
ARM A Patients receive oxaliplatin intravenously IV over 2 hours leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease
ARM B closed to accrual as of 612005--currently enrolled patients may cross over to arm I for remainder of therapy Patients receive irinotecan hydrochloride IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease
ARM C closed to accrual as of 612005--currently enrolled patients may cross over to arm I for remainder of therapy Patients receive 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
ARM D Patients receive cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin leucovorin calcium and fluorouracil as in arm A Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease
ARM E closed to accrual as of 612005--currently enrolled patients may cross over to arm D for remainder of therapy Patients receive cetuximab as in arm D and irinotecan hydrochloride leucovorin calcium and fluorouracil as in arm B Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease
ARM F closed to accrual as of 612005--currently enrolled patients may cross over to arm D for remainder of therapy Patients receive cetuximab as in arm D and chemotherapy as in arm C
ARM G added as of 8182008 mutant KRAS or KRAS not evaluable patients Locally directed therapy
NOTE Cetuximab is administered over 2 hours at a higher dose on day 1 of course 1 only
Quality of life QOL is assessed at baseline 3 months and at the end of therapy As of 8182008 QOL was discontinued
Patients are followed for a maximum of 8 years from randomization
I Disease-free Survival Arms A and D Wild-type KRAS Patients
SECONDARY OBJECTIVES
I Disease-free Survival Arms A and D Mutant KRAS Patients II Disease-free Survival III Overall Survival IV Toxicity
OUTLINE This is a randomized multicenter study Patients are stratified according to positive lymph node involvement 1-3 vs 4 or more histology high poorly differentiated or undifferentiated vs low well to moderately differentiated and clinical T stage T1 or T2 vs T3 vs T4 Patients are randomized to 1 of 6 treatment arms as of 612005 patients are randomized to treatment arms I and IV only arms II III V and VI are closed to accrual As of 8182008 pre-screening for KRAS status was added with mutant KRAS or KRAS not evaluable patients put on arm G and wild-type KRAS patients randomized between arm A and arm D
ARM A Patients receive oxaliplatin intravenously IV over 2 hours leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease
ARM B closed to accrual as of 612005--currently enrolled patients may cross over to arm I for remainder of therapy Patients receive irinotecan hydrochloride IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease
ARM C closed to accrual as of 612005--currently enrolled patients may cross over to arm I for remainder of therapy Patients receive 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
ARM D Patients receive cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin leucovorin calcium and fluorouracil as in arm A Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease
ARM E closed to accrual as of 612005--currently enrolled patients may cross over to arm D for remainder of therapy Patients receive cetuximab as in arm D and irinotecan hydrochloride leucovorin calcium and fluorouracil as in arm B Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease
ARM F closed to accrual as of 612005--currently enrolled patients may cross over to arm D for remainder of therapy Patients receive cetuximab as in arm D and chemotherapy as in arm C
ARM G added as of 8182008 mutant KRAS or KRAS not evaluable patients Locally directed therapy
NOTE Cetuximab is administered over 2 hours at a higher dose on day 1 of course 1 only
Quality of life QOL is assessed at baseline 3 months and at the end of therapy As of 8182008 QOL was discontinued
Patients are followed for a maximum of 8 years from randomization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000355132 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA025224 |
| N0147 | None | None | None |
| U10CA025224 | NIH | None | None |