Prospective, Open-labelled, Phase II Study, of the Administration of Desmopressin in Patients With Colorectal Cancer, With or Without Metastasis, With Rectal Bleeding, Before Treatment With Surgery and/or Chemotherapy and/or Radiotherapy.
Colorectal cancer is the third cause of cancer in men and women, according to data recently
published in the United Sates, and the third cause of death in the same population. Ninety
percent (90%) of patients have symptoms at the time of diagnosis, being rectal bleeding the
most frequent one (50% of cases). Bleeding, mainly mild or moderate, has no specific
treatment, and during the staging of the disease, can not be controlled.
Desmopressin, a synthetic analogue of vasopressin, is a selective agonist of the receptor V2
of vasopressin, inducing, among others, an haemostatic effect. Interestingly, the expression
of this receptor has been described in human gastrointestinal tract, including colon and
rectum and in colorectal tumors. Moreover, desmopressin has shown a significant antitumor
activity in preclinical murine models of colorectal cancer.
This is a dose finding study, to investigate a new indication of desmopressin as an
haemostatic agent in patients with colorectal cancer with mild to moderate rectal bleeding.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Presence or absence of grade 3 or 4 adverse events related to the study drug, in a maximum of 2 out of 6 patients assessed in each dose level.
A total of 6 groups with 3 patients each, with different dose ranges and dosing schedules will be assessed. The number of patients in each group with grade 3 or 4 adverse events, including clinical or analytical findings, will be determined in order to stablish the maximum torerated dose.
Up to one week after the administration of the first dose
Enrique Roca, MD
Hospital de Gastroenterologia ¨B. Udaondo¨
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica