Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084773
Status:
COMPLETED
Last Update Posted:
2015-12-22
First Post:
2004-06-10
Brief Title:
Neoadjuvant Cetuximab Fluorouracil and Pelvic Irradiation in Treating Patients With Locally Advanced or Locally Recurrent Rectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Pilot Clinical Trial of Preoperative Cetuximab With Concurrent Continuous Infusion Fluorouracil and Pelvic Radiation in Patients With Local-Regionally Advanced Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2015-12
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:
RATIONALE Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy such as fluorouracil work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Giving cetuximab with fluorouracil and radiation therapy may kill more tumor cells
Detailed Description:
OBJECTIVES
Primary
Determine the safety profile of neoadjuvant cetuximab fluorouracil and pelvic irradiation in patients with locally advanced or locally recurrent rectal cancer
Secondary
Determine the activity of this regimen in terms of pathological complete response rate in these patients
OUTLINE This is a non-randomized open-label pilot study
Patients receive cetuximab IV over 1-2 hours on days 1 8 15 22 29 36 43 50 57 and 64 and fluorouracil IV continuously on days 1-42 Patients undergo whole-pelvic radiotherapy once daily on days 1-5 8-12 15-19 22-26 29-33 and 36-40 Treatment continues in the absence of disease progression or unacceptable toxicity
Approximately 1-3 weeks after completion of study treatment patients undergo surgical resection followed by adjuvant chemotherapy off-study
Patients are followed for up to 5 years
Primary
Determine the safety profile of neoadjuvant cetuximab fluorouracil and pelvic irradiation in patients with locally advanced or locally recurrent rectal cancer
Secondary
Determine the activity of this regimen in terms of pathological complete response rate in these patients
OUTLINE This is a non-randomized open-label pilot study
Patients receive cetuximab IV over 1-2 hours on days 1 8 15 22 29 36 43 50 57 and 64 and fluorouracil IV continuously on days 1-42 Patients undergo whole-pelvic radiotherapy once daily on days 1-5 8-12 15-19 22-26 29-33 and 36-40 Treatment continues in the absence of disease progression or unacceptable toxicity
Approximately 1-3 weeks after completion of study treatment patients undergo surgical resection followed by adjuvant chemotherapy off-study
Patients are followed for up to 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 |
|---|---|---|---|
| MSKCC-04006 | None | None | None |