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Sponsors and Collaborators: |
Johannes Gutenberg University Mainz Pfizer |
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Information provided by: | Johannes Gutenberg University Mainz |
ClinicalTrials.gov Identifier: | NCT00411151 |
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.
Condition | Intervention | Phase |
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Adenocarcinoma of Stomach Barrett Esophagus |
Drug: Sunitinib-Malate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Multicenter Phase II Trial of Sunitinib for Patients With Chemo-Refractory Metastatic Gastric Cancer |
Estimated Enrollment: | 50 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function as defined by the following criteria:
Exclusion Criteria:
Intake of non-permitted concomitant drugs. (The coordinating investigator should be contacted to discuss the individual case.)
Any of the following events (in any grade) prior to starting the trial treatment:
Germany | |
Charité, Campus Benjamin Franklin | |
Berlin, Germany, 12200 | |
Germany, Baden-Würtemberg | |
Universitätsklinikum Tübingen | |
Tübingen, Baden-Würtemberg, Germany, 72076 | |
Universität Heidelberg, Nationales Zentrum für Tumorerkrankungen | |
Heidelberg, Baden-Würtemberg, Germany, 69120 | |
Germany, Bayern | |
Klinikum der Universität Würzburg | |
Würzburg, Bayern, Germany, 97070 | |
TU München, Klinikum rechts der Isar, II. Med. Klinik und Poliklinik | |
München, Bayern, Germany, 81675 | |
Germany, Nordrhein-Westfalen | |
Universitätsklinikum der GHS Essen, Innere Klinik und Poliklinik, Tumorforschung | |
Essen, Nordrhein-Westfalen, Germany, 45122 | |
Universitätsklinik zu Köln, Klinik I für Innere Medizin | |
Köln, Nordrhein-Westfalen, Germany, 50937 | |
Germany, Rheinland-Pfalz | |
Klinikum der Johannes Gutenberg-Universität Mainz | |
Mainz, Rheinland-Pfalz, Germany, 55131 | |
Germany, Saarland | |
Universitätsklinikum des Saarlandes | |
Homburg/Saar, Saarland, Germany, 66421 | |
Germany, Sachsen | |
Universitätsklinikum Carl Gustav Carus, Med. Klinik I | |
Dresden, Sachsen, Germany, 01307 | |
Germany, Sachsen-Anhalt | |
Otto-von-Guericke-Universität Magdeburg | |
Magdeburg, Sachsen-Anhalt, Germany, 39120 |
Principal Investigator: | Markus Moehler, MD | Johannes-Gutenberg-University of Mainz, I. Dept. Internal Medicine |
Responsible Party: | Johannes Gutenberg University Mainz ( Markus Moehler, MD ) |
Study ID Numbers: | GC-SU-2006, KKS 2005-015 |
Study First Received: | December 11, 2006 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00411151 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Adenocarcinoma of esophagogastric junction Adenocarcinoma of lower esophagus (Barrett carcinoma) |
Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Stomach cancer Carcinoma Digestive System Abnormalities Digestive System Diseases Stomach Diseases |
Sunitinib Stomach Neoplasms Gastrointestinal Neoplasms Barrett Esophagus Esophageal Diseases Adenocarcinoma Congenital Abnormalities Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |