Colorectal CancerPhase 2NCT01623206
Desmopressin (DDAVP) in Patients With Colorectal Cancer and Rectal Bleeding
A Phase 2 study testing Desmopressin in people with Colorectal Cancer and Rectal Bleeding, run by Laboratorio Elea Phoenix S.A. at 2 sites in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Rectal Bleeding
- What is being tested?
- Desmopressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesArgentina
- Study dates
- Apr 2013to Aug 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Argentina2 sites
Hospital de Gastroenterologia ¨B.Udaondo¨
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1264AAA
Instituto de Oncología "Alexander Fleming"
Ciudad Autónoma de Buenos Aires, Buenos Aires
About this study
Official title: 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.
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.
Read the detailed description
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.
- Conditions
- Colorectal Cancer, Rectal Bleeding
- Being tested
- Desmopressin
- Medical subject headings
- Colorectal Neoplasms, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
Dose groups: Group 1: 0.25 µg/kg/day; Group 2: 0.25 µg/kg/12 hours; Group 3: 0.50 µg/kg/12 hours; Group 4: 1 µg/kg/day; Group 5: 1 µg/kg/12 hours; Group 6: 2 µg/kg/day.
All groups will receive desmopressin intravenously, in a 15-20 minutes infusion, one or two times a day. The administration will be repeated 24 hours after the first infusion.
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin | Experimental | Four dose levels and two dosing schedules with 3 patients in each group. Receives: Drug: Desmopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 tolerated dose.
Measured: Up to one week after the administration of the first dose
Secondary outcomes (4)
Number of patients with grade 3 or 4 local adverse events
Once the maximum tolerated dose is determined, other 12 patients will be assessed to evaluate safety and tolerability of the study drug when administered as monotherapy.
Measured: Up to one week after the administration of the first dose
Number of patients with grade 3 or 4 systemic adverse events
Once the maximum tolerated dose is determined, other 12 patients will be assessed to evaluate safety and tolerability of the study drug when administered as monotherapy.
Measured: Up to one week after the administration of the first dose
Number of withdrawn from treatment
Measured: Up to one week after the administration of the first dose
Number of patients with partial or complete response in clinical endpoints
Clinical endpoints such us rectal bleeding, mucorrhea, evacuatory attempts and rectal pain will be assessed before and after treatment with the study drug.
Response will be classified as complete or partial response.
Measured: Up to one week after the administration of the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startApr 2013
- Primary completionJul 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorio Elea Phoenix S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enrique Roca, MD, Principal investigator, Hospital de Gastroenterologia ¨B. Udaondo¨
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623206
- Sponsor's protocol ID
- DDAVP-R01-02
- Status last verified
- Aug 2017
- First submitted
- 28 May 2012
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Iseas S, Roca EL, O'Connor JM, Eleta M, Sanchez-Luceros A, Di Leo D, Tinelli M, Fara ML, Spitzer E, Demarco IA, Ripoll GV, Pifano M, Garona J, Alonso DF. Administration of the vasopressin analog desmopressin for the management of bleeding in rectal cancer patients: results of a phase I/II trial. Invest New Drugs. 2020 Oct;38(5):1580-1587. doi: 10.1007/s10637-020-00914-5. Epub 2020 Mar 12.
PubMed 32166534
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01623206
- Acronym / sponsor ID
- DDAVP-R01-02
- Conditions
- Colorectal Cancer, Rectal Bleeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Laboratorio Elea Phoenix S.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jul 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desmopressin | Experimental | Drug: DesmopressinFour dose levels and two dosing schedules with 3 patients in each group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesmopressinDose groups: Group 1: 0.25 µg/kg/day; Group 2: 0.25 µg/kg/12 hours; Group 3: 0.50 µg/kg/12 hours; Group 4: 1 µg/kg/day; Group 5: 1 µg/kg/12 hours; Group 6: 2 µg/kg/day. All groups will receive desmopressin intravenously, in a 15-20 minutes infusion, one or two times a day. The administration will be repeated 24 hours after the first infusion. | Drug | Desmopressin |
Primary outcome
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.
Time frame: Up to one week after the administration of the first dose
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 tolerated dose.
4 secondary outcomes
Number of patients with grade 3 or 4 local adverse events
Time frame: Up to one week after the administration of the first dose
Number of patients with grade 3 or 4 systemic adverse events
Time frame: Up to one week after the administration of the first dose
Number of withdrawn from treatment
Time frame: Up to one week after the administration of the first dose
Number of patients with partial or complete response in clinical endpoints
Time frame: Up to one week after the administration of the first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Derived from this study: PubMed 32166534Iseas S, Roca EL, O'Connor JM, Eleta M, Sanchez-Luceros A, Di Leo D, Tinelli M, Fara ML, Spitzer E, Demarco IA, Ripoll GV, Pifano M, Garona J, Alonso DF. Administration of the vasopressin analog desmopressin for the management of bleeding in rectal cancer patients: results of a phase I/II trial. Invest New Drugs. 2020 Oct;38(5):1580-1587. doi: 10.1007/s10637-020-00914-5. Epub 2020 Mar 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrique Roca, MD principal investigator
Hospital de Gastroenterologia ¨B. Udaondo¨
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Desmopressin in people with Colorectal Cancer and Rectal Bleeding, run by Laboratorio Elea Phoenix S.A. at 2 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Up to one week after the administration of the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01623206, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.