Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411151
Status:
COMPLETED
Last Update Posted:
2011-01-20
First Post:
2006-12-11
Brief Title:
Efficacy and Safety of Sunitinib in Metastatic Gastric Cancer
Sponsor:
Johannes Gutenberg University Mainz
Organization:
Johannes Gutenberg University Mainz
Study Overview
Official Title:
An Open-label Multicenter Phase II Trial of Sunitinib for Patients With Chemo-refractory Metastatic Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2011-01
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:
This trial will be conducted to evaluate the efficacy safety and tolerability of sunitinib sunitinib-malate as a second-line palliative therapy in metastatic gastric cancer Despite the efforts in front-line therapy second-line protocols have not yet been established in randomized clinical trials for those patients Although many patients are still in good performance status and present with low tumor burden after failure of first-line chemotherapy they may clearly benefit from second-line treatment Increasingly more metachronic metastatic patients are urging for new platinum-free therapeutic options due to the fast-growing use of neo- adjuvant platin-based protocols
So far only sparse data on chemotherapy are available after failure of platin-based protocols Nearly only irinotecan-containing combinations have properly been analyzed and produced excellent response rates and survival times of up to 30 and 76 months respectively However irinotecan has not been approved yet for this indication In addition as irinotecan-containing regimens have been submitted for approval for first-line therapy second-line regimens in irinotecan-refractory patients have not been evaluated in any trial Thus there is an urgent need to establish new second-line treatment options for both cisplatinum- or irinotecan-combination refractory patients with advanced or metastatic gastric cancer
Sunitinib inhibits the receptor tyrosine kinases RTKs involved in tumor proliferation and angiogenesis specifically the VEGFR PDGFR KIT FLT-3 and RET The VEGF pathway has been shown to be a significant factor in metastatic gastric cancer In gastric carcinoma cells VEGF ligands and its receptors are definitely involved in the process of tumor progression KDR and FLT-1 are expressed widely and VEGF stimulated KDR-positive tumor cell growth directly The ligand VEGF-C has also been shown to be involved in progression of human gastric carcinoma particularly via lymphangiogenesis In addition peritoneal metastases of some cancers such as gastric cancers were largely dependent on VEGF Therefore patients with chemo-refractory metastatic gastric cancer might benefit from VEGFR inhibitory therapy with sunitinib
So far only sparse data on chemotherapy are available after failure of platin-based protocols Nearly only irinotecan-containing combinations have properly been analyzed and produced excellent response rates and survival times of up to 30 and 76 months respectively However irinotecan has not been approved yet for this indication In addition as irinotecan-containing regimens have been submitted for approval for first-line therapy second-line regimens in irinotecan-refractory patients have not been evaluated in any trial Thus there is an urgent need to establish new second-line treatment options for both cisplatinum- or irinotecan-combination refractory patients with advanced or metastatic gastric cancer
Sunitinib inhibits the receptor tyrosine kinases RTKs involved in tumor proliferation and angiogenesis specifically the VEGFR PDGFR KIT FLT-3 and RET The VEGF pathway has been shown to be a significant factor in metastatic gastric cancer In gastric carcinoma cells VEGF ligands and its receptors are definitely involved in the process of tumor progression KDR and FLT-1 are expressed widely and VEGF stimulated KDR-positive tumor cell growth directly The ligand VEGF-C has also been shown to be involved in progression of human gastric carcinoma particularly via lymphangiogenesis In addition peritoneal metastases of some cancers such as gastric cancers were largely dependent on VEGF Therefore patients with chemo-refractory metastatic gastric cancer might benefit from VEGFR inhibitory therapy with sunitinib
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 |
|---|---|---|---|
| KKS 2005-015 | None | None | None |