Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514020
Status:
COMPLETED
Last Update Posted:
2012-11-01
First Post:
2007-08-08
Brief Title:
Fluorouracil Oxaliplatin and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction GEJ Tumors A Phase II Study
Status:
COMPLETED
Status Verified Date:
2012-10
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 Drugs used in chemotherapy such as fluorouracil oxaliplatin 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 more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving fluorouracil together with oxaliplatin and leucovorin works in treating patients with metastatic stomach cancer or gastroesophageal junction cancer
PURPOSE This phase II trial is studying how well giving fluorouracil together with oxaliplatin and leucovorin works in treating patients with metastatic stomach cancer or gastroesophageal junction cancer
Detailed Description:
OBJECTIVES
Primary
Compare the response rate in patients with good risk genotype TSER22 or TSER23 genotype low TS expression to historical control response rates in non-genotype selected patients
OUTLINE This is a multicenter study
Patients receive oxaliplatin IV over 2 hours leucovorin calcium IV over 2 hours and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression
Available tumor tissue samples are assessed for expression of TS at the mRNA and protein levels The results are correlated with germline and tumor TSER genotypes as well as response to the study treatment regimen Polymorphisms in other genes associated with treatment outcome or toxicity are also assessed
After completion of study treatment patients are followed periodically for 4 years
Primary
Compare the response rate in patients with good risk genotype TSER22 or TSER23 genotype low TS expression to historical control response rates in non-genotype selected patients
OUTLINE This is a multicenter study
Patients receive oxaliplatin IV over 2 hours leucovorin calcium IV over 2 hours and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression
Available tumor tissue samples are assessed for expression of TS at the mRNA and protein levels The results are correlated with germline and tumor TSER genotypes as well as response to the study treatment regimen Polymorphisms in other genes associated with treatment outcome or toxicity are also assessed
After completion of study treatment patients are followed periodically for 4 years
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 |
|---|---|---|---|
| VU-VICC-GI-0716 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA068485 |
| P30CA068485 | NIH | None | None |