Gastric Adenocarcinoma Clinical Trial
Official title:
An Open-label, Multicenter Phase II Trial of Sunitinib for Patients With Chemo-refractory Metastatic Gastric Cancer
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 7.6 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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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