Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020761
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2001-07-11
Brief Title:
Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study Of Irinotecan Camptosar And Paclitaxel Taxol In Patients With Adenocarcinoma Of The Upper Gastrointestinal Tract
Status:
COMPLETED
Status Verified Date:
2012-07
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 paclitaxel in treating patients who have metastatic or recurrent cancer of the esophagus or stomach
PURPOSE Phase II trial to study the effectiveness of combining irinotecan and paclitaxel in treating patients who have metastatic or recurrent cancer of the esophagus or stomach
Detailed Description:
OBJECTIVES
Determine the antitumor activity of irinotecan and paclitaxel in patients with metastatic or recurrent adenocarcinoma of the esophagus or stomach
Determine the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study Patients are stratified according to diagnosis adenocarcinoma of the esophagus gastroesophageal junction or gastric cardia vs adenocarcinoma of the rest of the stomach
Patients receive irinotecan IV over 90 minutes followed by paclitaxel IV over 3 hours on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed at 30 days and then every 3 months thereafter
PROJECTED ACCRUAL A total of 26-54 patients 13-27 per stratum will be accrued for this study
Determine the antitumor activity of irinotecan and paclitaxel in patients with metastatic or recurrent adenocarcinoma of the esophagus or stomach
Determine the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study Patients are stratified according to diagnosis adenocarcinoma of the esophagus gastroesophageal junction or gastric cardia vs adenocarcinoma of the rest of the stomach
Patients receive irinotecan IV over 90 minutes followed by paclitaxel IV over 3 hours on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed at 30 days and then every 3 months thereafter
PROJECTED ACCRUAL A total of 26-54 patients 13-27 per stratum will be accrued for this study
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 |
|---|---|---|---|
| NCI-G01-1957 | None | None | None |
| UCLA-0001048 | None | None | None |