Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256321
Status:
TERMINATED
Last Update Posted:
2019-02-08
First Post:
2005-11-18
Brief Title:
CelecoxibOxaliplatinCapecitabine for GastricGastroesophageal Junction Carcinoma
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
A Phase II Study of CelecoxibOxaliplatinCapecitabine Combination Chemotherapy for UnresectableRecurrent or Metastatic GastricGastroesophageal Junction Carcinoma
Status:
TERMINATED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed due to poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gastric cancer is the second most common neoplasm in the world Early diagnosis and surgical resection improve the survival and the chance of cure Unfortunately majority of cases are diagnosed at advanced stage with only 20 of the patients presenting with localized disease The five-year survival for gastric cancer of all stages remains at a dismal 8 Chemotherapy has been used for advanced gastric cancer but with unsatisfactory results Therefore new approaches are needed for these patients Among the newer chemotherapy regimens for advanced gastric cancer include a combination of oral 5-Fluoro-Uracil FU-based compound called CapecitabineXeloda and Oxaliplatin A few phase II studies suggest that the combination regimen is active with overall response rates ranging 30-40 Several preclinical and clinical studies have shown that the expression of cyclooxygenase enzyme IICOX-2 is upregulated in many pre-neoplastic and neoplastic lesions Furthermore there appears to be an association with the overexpression of Cox-2 and the invasiveness of cancer and prognosis Finally preclinical and clinical studies suggest selective Cox-2 inhibitors can induce apoptosis in gastric cancer cells and retard tumor progression Therefore there is a strong rationale for the combination of a selective Cox-2 inhibitor Celecoxib with Capecitabine and Oxaliplatin in a therapeutic phase II trial for patients with advanced or recurrent gastric cancer
Detailed Description:
None
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 |
|---|---|---|---|
| 2003-3414 | OTHER | University of California Irvine | None |