Malignant Ascites Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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