Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030862
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2002-02-14
Brief Title:
Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Single-Arm Trial Of CPT-11 Irinotecan HC1 Camptosar InjectionCisplatin In Patients With Advanced Esophageal Cancer
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining irinotecan and cisplatin in treating patients who have locally advanced unresectable or metastatic cancer of the esophagus that has not been previously treated
PURPOSE Phase II trial to study the effectiveness of combining irinotecan and cisplatin in treating patients who have locally advanced unresectable or metastatic cancer of the esophagus that has not been previously treated
Detailed Description:
OBJECTIVES
Determine the objective tumor response rate in patients with previously untreated locally advanced unresectable or metastatic esophageal cancer treated with irinotecan and cisplatin
Determine the dysphagia relief in patients treated with this regimen
Determine the time to progression and overall survival of patients treated with this regimen
Determine the safety of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive cisplatin IV over 1-2 hours and irinotecan IV over 30 minutes on days 1 and 8 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study within 1 year
Determine the objective tumor response rate in patients with previously untreated locally advanced unresectable or metastatic esophageal cancer treated with irinotecan and cisplatin
Determine the dysphagia relief in patients treated with this regimen
Determine the time to progression and overall survival of patients treated with this regimen
Determine the safety of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive cisplatin IV over 1-2 hours and irinotecan IV over 30 minutes on days 1 and 8 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study within 1 year
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069204 | REGISTRY | None | None |
| PHARMACIA-440E-ONC-0020-319 | None | None | None |
| NCI-G01-2050 | Registry Identifier | PDQ Physician Data Query | None |