Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061932
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2003-06-05
Brief Title:
Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of PS-341 Alone or in Combination With Irinotecan in Patients With Adenocarcinoma of the Gastroesophageal Junction GEJ or Stomach
Status:
COMPLETED
Status Verified Date:
2021-01
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:
This phase II trial is studying how well bortezomib with or without irinotecan works in treating patients with gastroesophageal junction or stomach cancer that can not be removed by surgery Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die Combining bortezomib with irinotecan may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the response rate for the combination of irinotecan and PS 341 in patients with previously untreated adenocarcinoma of the stomach or GEJ
II To determine the response rate for PS341 in patients with previously treated adenocarcinoma of the stomach or GEJ
III To determine the toxicities and recovery from toxicities for patients receiving PS 341 alone or in combination with irinotecan IV To perform GeneChip analysis on biopsy specimens prior to and subsequent to treatment with PS341 to determine changes in patterns of gene expression
OUTLINE Patients are stratified stratum 2 closed to accrual as of 9192006 according to prior chemotherapy for advanced disease yes vs no
STRATUM 1 Previously untreated patients Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 and irinotecan IV over 90 minutes on days 1 and 8
STRATUM 2 Previously treated patients closed to accrual as of 9192006 Patients receive bortezomib as in stratum 1
In both strata courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
I To determine the response rate for the combination of irinotecan and PS 341 in patients with previously untreated adenocarcinoma of the stomach or GEJ
II To determine the response rate for PS341 in patients with previously treated adenocarcinoma of the stomach or GEJ
III To determine the toxicities and recovery from toxicities for patients receiving PS 341 alone or in combination with irinotecan IV To perform GeneChip analysis on biopsy specimens prior to and subsequent to treatment with PS341 to determine changes in patterns of gene expression
OUTLINE Patients are stratified stratum 2 closed to accrual as of 9192006 according to prior chemotherapy for advanced disease yes vs no
STRATUM 1 Previously untreated patients Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 and irinotecan IV over 90 minutes on days 1 and 8
STRATUM 2 Previously treated patients closed to accrual as of 9192006 Patients receive bortezomib as in stratum 1
In both strata courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| N01CM62204 | NIH | None | httpsreporternihgovquickSearchN01CM62204 |