Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354224
Status:
TERMINATED
Last Update Posted:
2018-07-16
First Post:
2006-07-19
Brief Title:
Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach Cancer
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
A Phase II Study of XELOX in Locally Advanced or Metastatic Gastric Cancer
Status:
TERMINATED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
due to low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as capecitabine and oxaliplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating patients with locally advanced unresectable or metastatic stomach cancer
PURPOSE This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating patients with locally advanced unresectable or metastatic stomach cancer
Detailed Description:
OBJECTIVES
Primary
Determine the response proportion in patients with locally advanced unresectable or metastatic gastric cancer treated with capecitabine and oxaliplatin
Secondary
Determine the tolerability and toxicity of this regimen in these patients
Determine the median and progression-free survival of patients treated with this regimen
OUTLINE This is an open-label study
Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-7 Treatment repeats every 14 days in the absence of unacceptable toxicity or disease progression
After completion of study treatment patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 46 patients will be accrued for this study
Primary
Determine the response proportion in patients with locally advanced unresectable or metastatic gastric cancer treated with capecitabine and oxaliplatin
Secondary
Determine the tolerability and toxicity of this regimen in these patients
Determine the median and progression-free survival of patients treated with this regimen
OUTLINE This is an open-label study
Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-7 Treatment repeats every 14 days in the absence of unacceptable toxicity or disease progression
After completion of study treatment patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 46 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000484638 | REGISTRY | PDQ Physician Data Query | None |
| MUSC-OX-33-064 | None | None | None |
| MUSC-HR-11497 | None | None | None |