Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002968
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
1999-11-01
Brief Title:
Edrecolomab in Treating Patients With Stage II Colon Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Study of Adjuvant Immunotherapy With Monoclonal Antibody 17-1A Versus No Adjuvant Therapy Following Resection for State II Modified Astler-Coller B2 Adenocarcinoma of the Colon
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Randomized phase III trial to compare the effectiveness of surgery with or without monoclonal antibody therapy in treating patients who have stage II colon cancer Monoclonal antibodies such as edrecolomab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells It is not yet known whether surgery to remove colon cancer is more effect with or without monoclonal antibody therapy
Detailed Description:
PRIMARY OBJECTIVES
I To determine whether adjuvant treatment with MoAb 17-1A will improve the probability of overall and disease-free survival and increase disease-free intervals in patients who have undergone resection of a Stage II colon cancer
II To determine whether alterations in the expression of cell cycle related genes thymidylate synthase p53 and the cyclin-dependent kinase inhibitors p21 and p27 predict the risk of survival and recurrence in this patient population
III To determine whether alterations in markers of metastatic potential-expression of DCC and measures of tumor angiogenesis microvascular density and vascular endothelial growth factor expression-predict the risk of survival and recurrence in this patient population
IV To determine whether a marker of cellular differentiation-sucrase isomaltase-predicts the risk of survival and recurrence in this patient population
V To determine whether DNA ploidy and cell proliferation are prognostic of tumor recurrence and overall survival in Stage II colon cancer
VI To determine whether interactions among these tumor markers identify subsets of patients with significantly altered outcome
VII To determine whether pathologic features including tumor grade tumor mitotic proliferation index tumor border configuration host lymphoid response to tumor and lymphatic vessel venous vessel and perineural invasion predict outcome in this patient population
OUTLINE This is a randomized study Patients are stratified according to degree of differentiation well vs moderately well vs poor vascular or lymphatic invasion no vs yes and preoperative serum CEA less than 50 ngmL vs at least 50 ngmL vs unknown Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive adjuvant edrecolomab IV over 2 hours on day 1 Treatment repeats every 28 days for 5 courses Patients must begin therapy no earlier than 7 days and no later than 42 days post-surgical resection Patients also undergo observation at 3 and 6 months post-randomization
Arm II Patients undergo observation at 3 and 6 months post-randomization
Patients are followed after the last course of edrecolomab arm I and at 12 months arm II All patients are followed every 6 months for 5 years
I To determine whether adjuvant treatment with MoAb 17-1A will improve the probability of overall and disease-free survival and increase disease-free intervals in patients who have undergone resection of a Stage II colon cancer
II To determine whether alterations in the expression of cell cycle related genes thymidylate synthase p53 and the cyclin-dependent kinase inhibitors p21 and p27 predict the risk of survival and recurrence in this patient population
III To determine whether alterations in markers of metastatic potential-expression of DCC and measures of tumor angiogenesis microvascular density and vascular endothelial growth factor expression-predict the risk of survival and recurrence in this patient population
IV To determine whether a marker of cellular differentiation-sucrase isomaltase-predicts the risk of survival and recurrence in this patient population
V To determine whether DNA ploidy and cell proliferation are prognostic of tumor recurrence and overall survival in Stage II colon cancer
VI To determine whether interactions among these tumor markers identify subsets of patients with significantly altered outcome
VII To determine whether pathologic features including tumor grade tumor mitotic proliferation index tumor border configuration host lymphoid response to tumor and lymphatic vessel venous vessel and perineural invasion predict outcome in this patient population
OUTLINE This is a randomized study Patients are stratified according to degree of differentiation well vs moderately well vs poor vascular or lymphatic invasion no vs yes and preoperative serum CEA less than 50 ngmL vs at least 50 ngmL vs unknown Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive adjuvant edrecolomab IV over 2 hours on day 1 Treatment repeats every 28 days for 5 courses Patients must begin therapy no earlier than 7 days and no later than 42 days post-surgical resection Patients also undergo observation at 3 and 6 months post-randomization
Arm II Patients undergo observation at 3 and 6 months post-randomization
Patients are followed after the last course of edrecolomab arm I and at 12 months arm II All patients are followed every 6 months for 5 years
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 |
|---|---|---|---|
| NCIC CTG CO14 | None | None | None |
| CLB-9581 | None | None | None |
| CDR0000065473 | None | None | None |
| C9581 | None | None | None |
| CAN-NCIC-CO14 | None | None | None |
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |