Perioperative Use of Desmopressin (DDAVP) in Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Laboratorio Elea S.A.C.I.F. y A.
Sponsor:
Information provided by (Responsible Party):
Laboratorio Elea S.A.C.I.F. y A.
ClinicalTrials.gov Identifier:
NCT01606072
First received: May 11, 2012
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

The propose for this study is to evaluate the safety and tolerability of desmopressin when administered perioperatively to patients with breast cancer undergoing surgery as first treatment, and select the optimum dose for the clinical development of the product.


Condition Intervention Phase
Breast Cancer
Drug: Desmopressin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Perioperative Administration of Desmopressin to Subjects With Breast Cancer: A Phase IIa, Dose-Escalation Study

Resource links provided by NLM:


Further study details as provided by Laboratorio Elea S.A.C.I.F. y A.:

Primary Outcome Measures:
  • Selection of the higher safe dose level for ensuing clinical trials [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    One of the three dose levels assessed in this study will be selected for further clinical testing in adults: 0,50 mg, 1,0 mg, 1,25 mg, 1,5 mg or 2,0 mg.


Secondary Outcome Measures:
  • Evidence of V2 Receptor Expression [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Evidence of CTC (CIRCULATING TUMOR CELLS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Evidence of Von Willebrand factor antigen (VWF:Ag) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Evidence of CTC (circulating tumor cells) [ Time Frame: 30 minutes pre surgery and 24 hours post the surgery ] [ Designated as safety issue: No ]
  • Evidence of CTC (circulating tumor cells) [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • Evidence of CTC (circulating tumor cells) [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
  • Evidence of CTC (circulating tumor cells) [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  • Evidence of CTC (circulating tumor cells) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Evidence of CTC (circulating tumor cells) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Evidence of Von Willebrand factor antigen (VWF:Ag) [ Time Frame: 120 minutes post the surgery ] [ Designated as safety issue: No ]
  • Evidence of VWF activity (ristocetin cofactor, VWF:RCo) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Evidence of VWF activity (ristocetin cofactor, VWF:RCo) [ Time Frame: 120 minutes post the surgery ] [ Designated as safety issue: No ]
  • Evidence of FVIII coagulant activity (FVIII:C) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Evidence of FVIII coagulant activity (FVIII:C) [ Time Frame: 120 minutes post the surgery ] [ Designated as safety issue: No ]
  • Evidence of euglobulin lysis time [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Evidence of euglobulin lysis time [ Time Frame: 120 minutes post the surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2011
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desmopressin Drug: Desmopressin
20 patients in 5 groups 4 each, advancing progressively to each dose level.

Detailed Description:

Breast cancer is one of the most commonly diagnosed malignancies among women, and its mortality is related to the capacity of tumor cells to invade and produce metastases. It is postulated that tumor manipulation during surgery results in the release of tumor cells into circulation or the lymphatic system, and that these released cells survive due to aggregation among them or with platelets through the formation of a fibrin layer on the embolus. Tumor cells surviving transportation through circulation will join blood vessels and invade vascular walls, forming metastases. The interruption of this process might reduce survival of tumor cells and thus the formation of metastases from breast cancer cells in the lungs or other tissues.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a. Female subjects from 21 to 60 years of age, who have voluntarily signed the informed consent form.

    b. Histological/cytological diagnosis of breast carcinoma obtained at least 21 days before inclusion into the study.

    c. Candidate for radical mastectomy and requiring resection of axillary lymph nodes or sentinel node.

    d. In case of women of childbearing potential, an adequate birth control method (intrauterine device, barrier methods, or tubal ligation) should be used throughout the study. Post-menopausal women should have menopause confirmed by biochemical parameters.

    e. Adequate organic function, defined by the following parameters:

    • Electrocardiogram (ECG) with no significant anomalies, performed within 14 days prior to surgery.
    • The following laboratory results, obtained 7 days before surgery:
    • Hemoglobin ≥ 11 g/dL
    • Total white blood cell count ≥ 4,000/mm3
    • Total neutrophil count 1,500/mm3
    • Platelet count within normal limits
    • Total bilirubin ≤1.5 x UNL or 2.5 x UNL in case of hepatic metastasis
    • Transaminases ALT/GPT and AST/GOT ≤ 1.5 x UNL
    • Creatinine clearance >50 mg/dL
    • CT scan with oral and endovenous contrast* of chest, pelvis, and abdomen, and bone scan, conducted within 28 days prior to surgery. Images taken not longer than 90 days before surgery are also acceptable.

      • In case contrast is contraindicated, CT with no contrast or MRI will be performed.

        f. Subject with performance status (ECOG) = 0.

Exclusion Criteria:

  • a. Synchronic bilateral breast cancer. b. Symptoms of metastasis or evidence of metastasis from images: chest spiral CT scan, abdomen/pelvis spiral CT scan, brain spiral CT/MRI (in case of brain metastasis signs), and bone scan.

    c. The patient is pregnant or breastfeeding. d. The patient is presently using hormonal contraceptives or under hormonal treatment. She would be eligible if oral contraceptives were discontinued or if the hormonal treatment finished 30 days before surgery and the patient agreed to use another contraceptive method.

    e. Patients with a history or presence of congestive heart failure, blood hypertension, angina pectoris or heart arrhythmia, thromboembolic disease, diabetes type I or II, or any underlying coronaropathy detected in pre-surgical evaluations.

    f. Mentally-impaired patients. g. Patients with known hypersensitivity to DDAVP or vasopressin, o with severe von Willebrand's disease (VWD), defined by a VWF activity <10%IU/dL, or type 2B VWD, defined by an increased ristocetin-induced platelet aggregation (RIPA) at low concentrations of ristocetin or with hemophilia.

    h. Patients with a history of seizures. i. Patients with renal impairment (creatinine clearance < 50 mL/min calculated by the Cockcroft-Gault formula), hyponatremia or with a history of hyponatremia.

    j. Patients with syndrome of inadequate secretion of antidiuretic hormone. k. Patients with positive serology for the hepatitis B or C virus and/or HIV. l. Patients with known hepatic disease (diagnosed cirrhosis, hepatic enzymes (GOT/GPT) > 1.5 x UNL, Total bilirubin > 1.5 x UNL).

    m. Patients with active infections. n. Patients with other malignant diseases, with the exception of, non-melanoma skin cancer, or cervix cancer in situ, or any other tumor that has received adequate treatment and shows a disease-free time ≥ 5 years.

    o. Patients participating in another clinical study or cases in which less than 4 weeks have elapsed since participation in another clinical study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606072

Contacts
Contact: Marcelo Tinelli 54 11 4379 4300 ext 1290 tinellim@elea.com
Contact: Roberto Gomez 54 11 4379 4300 ext 1415 gomezr@elea.com

Locations
Argentina
Hospital Interzonal General De Agudos EvaPeron Recruiting
Buenos Aires, Argentina
Contact: Dra. Ruth Weinberg    (011) 4724-3000 ext 3076      
Principal Investigator: Dra. Ruth Weinberg         
Sponsors and Collaborators
Laboratorio Elea S.A.C.I.F. y A.
Investigators
Principal Investigator: Dra. Ruth Weinberg Hospital Interzonal General De Agudos Eva Peron
  More Information

No publications provided

Responsible Party: Laboratorio Elea S.A.C.I.F. y A.
ClinicalTrials.gov Identifier: NCT01606072     History of Changes
Other Study ID Numbers: DDAVP
Study First Received: May 11, 2012
Last Updated: July 9, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Laboratorio Elea S.A.C.I.F. y A.:
DDAVP

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014