Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066716
Status:
COMPLETED
Last Update Posted:
2009-12-08
First Post:
2003-08-06
Brief Title:
Celecoxib Paclitaxel and Carboplatin in Treating Patients With Cancer of the Esophagus
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
A Phase II Study Of Preoperative CelecoxibPaclitaxelCarboplatin For Squamous Cell And Adenocarcinoma Of The Esophagus
Status:
COMPLETED
Status Verified Date:
2009-12
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 Drugs used in chemotherapy such as paclitaxel and carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die Celecoxib may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug Celecoxib may also stop the growth of tumor cells by stopping blood flow to the tumor andor may block the enzymes necessary for their growth Combining celecoxib with paclitaxel and carboplatin before surgery may shrink the tumor so that it can be removed during surgery Giving celecoxib alone after surgery may kill any remaining tumor cells
PURPOSE This phase II trial is studying how well giving celecoxib together with paclitaxel and carboplatin works in treating patients who are undergoing surgery for esophageal cancer
PURPOSE This phase II trial is studying how well giving celecoxib together with paclitaxel and carboplatin works in treating patients who are undergoing surgery for esophageal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the rate of complete pathological response andor minimal residual microscopic disease in patients with squamous cell or adenocarcinoma of the esophagus treated with preoperative celecoxib paclitaxel and carboplatin
Secondary
Determine the clinical response rate of patients treated with this regimen
Determine the chemotherapy-related toxicity of this regimen in these patients
Determine the time to progression disease-free survival and overall survival of patients treated with this regimen
OUTLINE Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on days 1 22 and 43 Patients also receive oral celecoxib twice daily beginning 3-7 days before the first dose of chemotherapy and continuing until the morning of planned surgical resection between days 64 and 71 Approximately 28-56 days after resection patients may resume oral celecoxib twice daily and continue for 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed periodically for 18 months after surgery
PROJECTED ACCRUAL A total of 39 patients will be accrued for this study within 18 months
Primary
Determine the rate of complete pathological response andor minimal residual microscopic disease in patients with squamous cell or adenocarcinoma of the esophagus treated with preoperative celecoxib paclitaxel and carboplatin
Secondary
Determine the clinical response rate of patients treated with this regimen
Determine the chemotherapy-related toxicity of this regimen in these patients
Determine the time to progression disease-free survival and overall survival of patients treated with this regimen
OUTLINE Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on days 1 22 and 43 Patients also receive oral celecoxib twice daily beginning 3-7 days before the first dose of chemotherapy and continuing until the morning of planned surgical resection between days 64 and 71 Approximately 28-56 days after resection patients may resume oral celecoxib twice daily and continue for 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed periodically for 18 months after surgery
PROJECTED ACCRUAL A total of 39 patients will be accrued for this study within 18 months
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 |
|---|---|---|---|
| NYWCCC-0902-463 | None | None | None |