Spots Global Cancer Trial Database for Bevacizumab as a Palliative Treatment for Patients With Symptomatic Malignant Ascites Due to Advanced-stage Gastrointestinal Cancers
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Trial Identification
Brief Title: Bevacizumab as a Palliative Treatment for Patients With Symptomatic Malignant Ascites Due to Advanced-stage Gastrointestinal Cancers
Official Title: Double-blind, Placebo-controlled, Randomized Phase II-study Investigating the Efficacy of Bevacizumab for Symptom Control in Patients With Malignant Ascites Due to Advanced-stage Gastrointestinal Cancers
Study ID: NCT01200121
Study Description
Brief Summary: Malignant ascites represents a severe clinical problem for physicians and patients being confronted with this common symptom of advanced-stage gastrointestinal cancer. Unfortunately, there is no standardized and evidence-based treatment for malignant ascites and therapies which are commonly being used are only temporarily effective. Newer modes of therapy, such as the application of the tri-functional antibody catumaxomab, are associated with significant side effects and are limited to patients in stages of good overall performance. Therefore, there is still an urgent need for more effective, longer-lasting, and less toxic modes of treatment for peritoneal effusions caused by gastrointestinal cancers. Preclinical data strongly suggest that bevacizumab might be a very effective agent for the treatment of malignant ascites, which is in large part caused by the hyperpermeability-promoting factor VEGF. Emerging clinical results from cancer patients with malignant ascites treated with bevacizumab add further support to this idea. Bevacizumab has been tested in a variety of large clinical trials, has a good toxicity profile, and is effective in a number of human cancers underlying malignant ascites. In the present study, Bevacizumab will be administered as an intraperitoneal infusion at an absolute standardized dosage of 400 mg. This dosage was chosen because it is comparable to the approved standard dosage for intravenous administration which was also used in both studies reporting the successful and safe intraperitoneal administration of Bevacizumab to patients with malignant ascites. Finally, a standardized dosage seems more practical in the particular patient population treated in this study.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Klinikum Ludwigsburg, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie, Ludwigsburg, Baden-Württemberg, Germany
Onkologische Schwerpunktpraxis, Wendlingen, Baden-Württemberg, Germany
Klinikum Deggendorf, Medizinische Klinik II, Deggendorf, Bayern, Germany
Medizinisches Versorgungszentrum, Onkologischer Schwerpunkt, Berlin-Zehlendorf, Berlin, Germany
Ernst von Bergmann Klinikum, Zentrum für Hämatologie/Onkologie/Strahlenheilkunde, Potsdam, Brandenburg, Germany
Klinikum der J.W. Goethe-Univerisität Frankfurt, Klinik für Allgemein- und Viszeralchirurgie, Frankfurt, Hessen, Germany
Klinikum Wetzlar-Braunfels, Medizinische Klinik II, Wetzlar, Hessen, Germany
Klinikum Region Hannover GmbH, Krankenhaus Siloah, Med. Klinik III (Hämatologie & Onkologie), Hannover, Niedersachsen, Germany
Onkologische Schwerpunktpraxis Hildesheim, Im Medicinum, Hildesheim, Niedersachsen, Germany
Kliniken Essen-Mitte, Klinik f. intern. Onkologie u. Hämatologie, Essen, Nordrhein-Westfalen, Germany
Universitätsklinikum Essen, Klinik für Innere Medizin - Tumorforschung, Essen, Nordrhein-Westfalen, Germany
Klinikum Leverkusen gGmbH, Medizinische Klinik III, Leverkusen, Nordrhein-Westfalen, Germany
Kliniken Maria Hilf GmbH, Krankenhaus St. Franziskus, Hämatologie/Onkologie/Gastroonkologie, Mönchengladbach, Nordrhein-Westfalen, Germany
Prosper-Hospital, Medizinische Klinik I, Recklinghausen, Nordrhein-Westfalen, Germany
Hämatologisch Onkologische Praxis Würselen, Würselen, Nordrhein-Westfalen, Germany
Johannes Gutenberg Universität, Universitätsklinikum, I. Medizinische Klinik und Poliklinik, Mainz, Rheinland-Pfalz, Germany
Universitätslinikum der Martin-Luther Universität Halle-Wittenberg, Klinik für Innere Medizin IV, Halle, Sachsen-Anhalt, Germany
Universitätsklinikum Leipzig, Klinik für Gastroenterologie und Rheumatologie, Leipzig, Sachsen, Germany
Internistische Praxis und Tagesklinik, Neustadt (Sachsen), Sachsen, Germany
Friedrich-Ebert-Krankenhaus GmbH, Klinik für Hämatologie, Onkologie/Nephrologie, Neumünster, Schleswig-Holstein, Germany
Vivantes Klinikum Am Urban, Klinik für Innere Medizin, Berlin, , Germany
VIVANTES Klinikum Neukölln, Onkologisches Zentrum Vivantes Süd, Berlin, , Germany
Charité (Campus Virchow-Klinikum), Med. Klinik mit Schwerpunkt Hämatologie und Onkologie, Berlin, , Germany
Vivantes Klinikum Spandau, Klinik für Innere Medizin, Berlin, , Germany
Universitätsklinikum Hamburg - Eppendorf, Onkologisches Zentrum, Hamburg, , Germany
MVZ für Innere Medizin in Hamburg-Eppendorf, Hamburg, , Germany
Contact Details
Name: Karin Jordan, Dr. med.
Affiliation: Universitätslinikum der Martin-Luther Universität Halle-Wittenberg
Role: PRINCIPAL_INVESTIGATOR
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