Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201747
Status:
COMPLETED
Last Update Posted:
2017-12-06
First Post:
2005-09-12
Brief Title:
Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Esophageal and Stomach Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Randomized Trial of Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Esophageal and Stomach Cancer
Status:
COMPLETED
Status Verified Date:
2017-12
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:
To determine the most efficacious of two combination regimens of sequential CPT-11 and MMC in patients with advanced and previously untreated esophageal and GE junction adenocarcinomas
Detailed Description:
Rationale Previous studies suggest that both irinotecan and Mytomycin C when administered alone have some efficacy against stomach cancer Based on laboratory testing researchers hypothesized that Mytomycin C may enhance the efficacy of irinotecan through an enzyme called Topoisomerase I In addition because Mytomycin C has severe side effects combining these chemotherapy agents together may allow for lower dosages resulting in greater efficacy and reduced side effects A recent study indicates that the combination of these drugs has promising anti-tumor activity against esophageal and stomach cancers The current study builds on previous research to explore the most effective schedule for administering these drugs together
Purpose This study is evaluating the combination of irinotecan and Mytomycin C on two different treatment schedules in patients with advanced esophageal and stomach cancers Characteristics of different genes will also be measured along with genetic and molecular changes by comparing test results from the beginning and end of the study
Treatment Patients in this study will receive irinotecan and Mytomycin C in one of two treatment schedules Both drugs will be administered in patients through an intravenous infusion A computer will randomly assign patients to a treatment group Group one will receive Mytomycin C on day 1 and irinotecan on days 2 and 9 Group two will receive Mytomycin C on days 1 and 8 and irinotecan on days 2 and 9 After day 9 patients in both groups will not be given any study drugs for almost three weeks to complete a four week cycle Several tests and exams will be given throughout the study to closely monitor patients Patients will continue receiving the study drugs until they experience disease growth or unacceptable side effects
Purpose This study is evaluating the combination of irinotecan and Mytomycin C on two different treatment schedules in patients with advanced esophageal and stomach cancers Characteristics of different genes will also be measured along with genetic and molecular changes by comparing test results from the beginning and end of the study
Treatment Patients in this study will receive irinotecan and Mytomycin C in one of two treatment schedules Both drugs will be administered in patients through an intravenous infusion A computer will randomly assign patients to a treatment group Group one will receive Mytomycin C on day 1 and irinotecan on days 2 and 9 Group two will receive Mytomycin C on days 1 and 8 and irinotecan on days 2 and 9 After day 9 patients in both groups will not be given any study drugs for almost three weeks to complete a four week cycle Several tests and exams will be given throughout the study to closely monitor patients Patients will continue receiving the study drugs until they experience disease growth or unacceptable side effects
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