Overview

Desmopressin (DDAVP) in Patients With Colorectal Cancer and Rectal Bleeding

Status:
Completed
Trial end date:
2017-08-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study is to find the maximum tolerated dose and preliminary efficacy of desmopressin as an haemostatic agent, when is administered to patients with colorectal cancer and rectal bleeding, before specific oncologic treatment with surgery and/or chemotherapy and/or radiotherapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Laboratorio Elea Phoenix S.A.
Laboratorio Elea S.A.C.I.F. y A.
Treatments:
Deamino Arginine Vasopressin
Criteria
Inclusion Criteria:

- Patients > 18 to < 80 years of age who have signed the informed consent form

- Histological diagnosis of rectal adenocarcinoma localized, locally advanced or
metastatic

- Treatment indication with chemotherapy and/or radiotherapy and/or surgery according to
disease stage

- Rectal bleeding associated with the primary tumor within 48 hours prior to study entry

- Acceptable organ function to be able to participate in the study, performed within 14
days prior to admission; defined by the following parameters:

- Electrocardiogram (ECG) without significant clinical abnormalities

- Haemoglobin greater than or equal to 8 g/dL

- Total leukocyte count greater than or equal to 4.0 x 10^9/L

- Absolute neutrophil count greater than or equal to 1.5 x 10^9/L

- Total platelet count greater to 100.0 x 10^9/L

- Total bilirubin less than or equal to 1.5 times the upper limit of normality
(ULN)

- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic
transaminase (SGPT) less than or equal to 1.5 times upper limit of normality
(ULN)

- Creatinine clearance greater than 50 ml/min

- Performance status (Eastern Cooperative Oncology Group [ECOG]) less than or equal to 2

- Patients with childbearing potential should use one of the following contraceptives
methods: intrauterine devices, barrier methods and tubal ligation

Exclusion Criteria:

- Colorectal cancer without bleeding evidences

- Pregnancy or lactation

- Use of hormonal contraceptives or treatments with sexual hormones in general

- Patients with other illnesses not adequately controlled such as congestive heart
failure, arterial blood pressure, unstable angina, severe cardiac arrhythmia,
thromboembolic disease, diabetes 1 or 2, any hidden coronary disease determined by
previous assessments

- Psychiatric diseases implying patient incompetence

- Known hypersensitivity to desmopressin or vasopressin

- Severe von Willebrand disease (vWD)(defined by vWF<10% Ui/dl) or 2B vWD (defined by
increased platelet agregation induced by ristocetin at low concentration) or
hemophilia A or B carriers

- History of seizures

- Renal insufficiency (Creatinine clearance < 50 ml/min), hyponatremia (serum sodium
lower than the lower limit of normality-UNL)or previous history of hyponatremia

- Syndrome of inappropriate antidiuretic hormone secretion (SIADH)

- Positive serology for hepatitis B, C or known human immunodeficiency virus (HIV)
infection

- Known liver disease (cirrhosis, liver enzymes greater than or equal to 1.5 times the
upper limit of normality or total bilirubin greater than or equal to 1.5 times the
upper limit of normality

- Active infections wich, according to the investigator judgement, coud interfere with
patient safety

- Other malignancies, with the exception of basal cell carcinoma, in situ cervical
carcinoma, or any other tumour adequately treated and with a disease-free period
greater than or equal to 5 years

- Patients receiving or having received other investigational drugs 30 days prior to
study entry