Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103103
Status:
TERMINATED
Last Update Posted:
2010-10-13
First Post:
2005-02-07
Brief Title:
Bortezomib Fluorouracil and Leucovorin in Treating Patients With Metastatic or Unresectable Stomach Cancer
Sponsor:
California Cancer Consortium
Organization:
California Cancer Consortium
Study Overview
Official Title:
A Phase II Combination Trial of PS-341 and 5-FULV in Gastric andor GE Junction Adenocarcinoma
Status:
TERMINATED
Status Verified Date:
2010-10
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 some of the enzymes needed for cell growth Drugs used in chemotherapy such as fluorouracil and leucovorin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving bortezomib together with fluorouracil and leucovorin may kill more tumor cells
PURPOSE This phase II trial is studying how well giving bortezomib together with fluorouracil and leucovorin works in treating patients with metastatic or unresectable stomach cancer
PURPOSE This phase II trial is studying how well giving bortezomib together with fluorouracil and leucovorin works in treating patients with metastatic or unresectable stomach cancer
Detailed Description:
OBJECTIVES
Primary
Determine response in patients with previously treated metastatic or unresectable gastric or gastroesophageal junction adenocarcinoma treated with bortezomib fluorouracil and leucovorin calcium
Secondary
Determine time to progression and overall survival of patients treated with this regimen
Determine the toxic effects of this regimen in these patients
OUTLINE This is a non-randomized multicenter study
Patients receive bortezomib IV over 3-5 seconds on days 1 8 and 15 One hour after completion of bortezomib patients receive leucovorin calcium IV and fluorouracil IV followed by fluorouracil IV continuously over 46 hours on days 1 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for survival
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study
Primary
Determine response in patients with previously treated metastatic or unresectable gastric or gastroesophageal junction adenocarcinoma treated with bortezomib fluorouracil and leucovorin calcium
Secondary
Determine time to progression and overall survival of patients treated with this regimen
Determine the toxic effects of this regimen in these patients
OUTLINE This is a non-randomized multicenter study
Patients receive bortezomib IV over 3-5 seconds on days 1 8 and 15 One hour after completion of bortezomib patients receive leucovorin calcium IV and fluorouracil IV followed by fluorouracil IV continuously over 46 hours on days 1 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for survival
PROJECTED ACCRUAL A total of 12-37 patients 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 |
|---|---|---|---|
| LAC-USC-3G036 | None | None | None |
| CCC-PHII-43 | None | None | None |
| NCI-5991 | None | None | None |