Desmopressin (DDAVP) in Patients With Colorectal Cancer and Rectal Bleeding (NCT01623206) | Clinical Trial Compass
CompletedPhase 2
Desmopressin (DDAVP) in Patients With Colorectal Cancer and Rectal Bleeding
Argentina30 participantsStarted 2013-04
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 contrac…
What they're measuring
1
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.
Timeframe: Up to one week after the administration of the first dose