Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084617
Status:
COMPLETED
Last Update Posted:
2015-05-01
First Post:
2004-06-10
Brief Title:
Phase II Study of Oxaliplatin Irinotecan and Capecitabine in Advanced GastricGastroesophageal Junction Carcinoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Oxaliplatin Irinotecan and Capecitabine in Advanced GastricGastroesophageal Junction Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-07
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:
Drugs used in chemotherapy such as oxaliplatin irinotecan and capecitabine work in different ways to stop tumor cells from dividing so they stop growing or die Giving more than one chemotherapy drug may kill more tumor cells This phase II trial is studying how well giving oxaliplatin together with irinotecan and capecitabine works in treating patients with metastatic or inoperable locally advanced gastric cancer or gastroesophageal junction adenocarcinoma cancer
Detailed Description:
PRIMARY OBJECTIVES
I To assess the total response rate of the oxaliplatin irinotecan and capecitabine drug combination in advanced gastricesophageal junction carcinoma
II To assess the duration of total responses of the oxaliplatin irinotecan and capecitabine drug combination in advanced gastricesophageal junction carcinoma
OUTLINE This is a multicenter study
Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1 8 15 and 22 and oral capecitabine twice daily on days 1-5 8-12 15-19 and 22-26 Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity
Patients are followed annually
PROJECTED ACCRUAL A total of 40-80 patients will be accrued for this study within 18 months
I To assess the total response rate of the oxaliplatin irinotecan and capecitabine drug combination in advanced gastricesophageal junction carcinoma
II To assess the duration of total responses of the oxaliplatin irinotecan and capecitabine drug combination in advanced gastricesophageal junction carcinoma
OUTLINE This is a multicenter study
Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1 8 15 and 22 and oral capecitabine twice daily on days 1-5 8-12 15-19 and 22-26 Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity
Patients are followed annually
PROJECTED ACCRUAL A total of 40-80 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 |
|---|---|---|---|
| U01CA062502 | NIH | None | httpsreporternihgovquickSearchU01CA062502 |
| CASE 1203 | None | None | None |
| CDR0000365464 | None | None | None |