A Randomized, Placebo-controlled Phase II Trial Investigating SUNITINIB Versus Placebo in Patients With Chemorefractory Advanced Adenocarcinoma of the Stomach or Lower Esophagus Treated With Chemotherapy FOLFIRI
In parallel to the efforts in front-line therapy, second-line protocols like
irinotecan-based regimens have been established in clinical trials for those patients. As
many patients are still in good performance status and present with low tumor burden after
failure of first-line chemotherapy, they clearly benefit from second-line treatment.
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.
The safety and efficacy of Sunitinib as single agent for the treatment of mGC has been
determined and support the proposed clinical study with FOLFIRI in combination with
Sunitinib in the treatment of patients with mGC.
Patients included in this trial suffer from advanced or metastatic adenocarcinoma of stomach
or lower esophagus. They have failed to respond at least to one standard palliative
first-line therapy (based on docetaxel and/or cisplatin plus 5-FU). Irinotecan/FA/5-FU can
be determined as one established second-line treatment to be available for these patients.
Taken together, treatment of those patients with Sunitinib combined with standard
chemotherapy FOLFIRI offers the chance to benefit from a new innovative therapy with
acceptable side effects.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
The primary endpoint is the Progression-free survival (PFS) according to RECIST V1.1.
Average time period: up to one year (participants are followed until progression or death)
Markus Moehler, MD
Johannes Gutenberg University Mainz, 1. Med. Klinik
Germany: Federal Institute for Drugs and Medical Devices