The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Sunitinib in Patients With Advanced Gastric Cancer and Treated With FOLFIRI
Official Title: 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
Study ID: NCT01020630
Brief Summary: This trial will be conducted to evaluate the efficacy, safety and tolerability of SUNITINIB as add-on therapy with a widely used second-line palliative FOLFIRI chemotherapy in patients with chemo-refractory advanced or metastatic adenocarcinoma of stomach or lower esophagus (mGC). There is a clear scientific rationale for the use of Sunitinib to treat patients with mGC. Despite recent therapeutic advances, the median overall survival (OS) in patients with mG is still ⤠12 months. Therefore, newer agents with novel mechanisms of action are desperately needed for treatment of these patients.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Universitätsmedizin Mainz, 1. Med. Klinik, Mainz, Rheinland-Pfalz, Germany
Gesundheitszentrum St. Marien, Amberg, , Germany
Helios Klinikum Berlin-Buch, Berlin, , Germany
Universitätsmedizin Berlin Charite, Berlin, , Germany
Evangelisches Krankenhaus Bielefeld, Bielefeld, , Germany
Universitätsklinikum Essen, Essen, , Germany
Kliniken Essen-Mitte, Essen, , Germany
Krankenhaus Nordwest, Frankfurt, , Germany
Martin-Luther-Universität Halle-Wittenberg, Halle, , Germany
MVZ fĂźr Innere Medizin in Hamburg-Eppendorf, Hamburg, , Germany
Universitätsklinikum des Saarlandes, Homburg, , Germany
Klinikum Ludwigsburg Medizinische Klinik I, Ludwigsburg, , Germany
Technische Universität Mßnchen, Mßnchen, , Germany
Universitätsklinikum Rostock Klinik fßr Innere Medizin, Rostock, , Germany
Leopoldina-Krankenhaus der Stadt Schweinfurt gGmbH, Schweinfurt, , Germany
Klinikum Weiden, Weiden, , Germany
Name: Markus Moehler, MD
Affiliation: Johannes Gutenberg University Mainz, 1. Med. Klinik
Role: PRINCIPAL_INVESTIGATOR