Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074009
Status:
COMPLETED
Last Update Posted:
2012-02-14
First Post:
2003-12-10
Brief Title:
Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicenter Open-Label Two-Stage Phase II Study Of PS-341 LDP-341 NSC 681239 In Patients With Unresectable Or Metastatic Gastric Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2009-12
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:
RATIONALE Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
PURPOSE Phase II trial to study the effectiveness of bortezomib in treating patients who have unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma
PURPOSE Phase II trial to study the effectiveness of bortezomib in treating patients who have unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of bortezomib in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
Secondary
Determine the toxicity of this drug in these patients
Determine possible predictors of response to this drug using pretreatment tumor immunohistochemistry in these patients
OUTLINE This is an open-label nonrandomized multicenter study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 15-33 patients will be accrued for this study within 5-12 months
Primary
Determine the efficacy of bortezomib in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
Secondary
Determine the toxicity of this drug in these patients
Determine possible predictors of response to this drug using pretreatment tumor immunohistochemistry in these patients
OUTLINE This is an open-label nonrandomized multicenter study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 15-33 patients will be accrued for this study within 5-12 months
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 |
|---|---|---|---|
| NCI-6003 | None | None | None |
| MSKCC-03101 | None | None | None |