Extended-release of Octreotide (LF-PB) for the Treatment of Lymphorrhea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chemi S.p.A.
ClinicalTrials.gov Identifier:
NCT01754285
First received: December 12, 2012
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

This is a phase II, multicenter, double-blind, double-dummy, parallel-group, placebo-controlled, study to evaluate LF-PB versus placebo in female patients with brest cancer who are undergoing breast surgery with axillary lymphnode dissection.

Recruited patients will be randomly assigned to one of the following treatment groups: Placebo, LF-PB 10 mg, LF-PB 20 mg and LF-PB 30 mg.

Mode of administration is single intramuscular (IM) injection so the treatments arms are as follows:

Placebo: 2 injections of placebo LF-PB 10 mg: 2 injections = placebo + 10 mg LF-PB 20 mg: 2 injections = placebo + 20 mg LF-PB 30 mg: 2 injections = 10 mg + 20 mg

The study will randomize a total of 120 patients (30 per arm) in about 10 Italian Sites.


Condition Intervention Phase
Lymphorrhea
Drug: LF-PB and Placebo
Drug: Placebo
Drug: LF-PB
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Double Dummy, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of LF-PB 10 mg, 20 mg, and 30 mg to Treat Lymphorrhea Post Axillary Dissection in Breast Cancer

Resource links provided by NLM:


Further study details as provided by Chemi S.p.A.:

Primary Outcome Measures:
  • effect of LF-PB 10 mg, 20 mg, and 30 mg on time to resolution of lymphorrhea; [ Time Frame: 12 weeks post surgery ] [ Designated as safety issue: No ]
    End of lymphorrhea will be declared when the lymph volume measured by the patient is < 50 ml/day in 2 consecutive days.

  • number of AEs and laboratory, ECG, vital sign abnormalities of LF-PB 10 mg, 20 mg, and 30 mg [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: Yes ]
    Safety and tolerability of LF-PB


Secondary Outcome Measures:
  • effects of LF-PB 10, 20, and 30 mg on the daily volume of lymph collected from the drain [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
    daily volume of lymph collected from the drain

  • number of complications related to lymphorrhea [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
    effect of LF-PB 10, 20 and 30 mg on complications related to lymphorrhea

  • PK profile (Cmax, Tmax, AUC0-t and possibly AUC0-inf and T1/2) of LF-PB 10, 20 and 30 mg [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
    PK parameters


Other Outcome Measures:
  • correlation between LF-PB exposures and efficacy after the administration of LF-PB 10 mg, 20 mg, and 30 mg [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
    correlation between exposure of the drug and efficacy


Enrollment: 114
Study Start Date: November 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LF-PB 10 mg
2 IM injections = placebo + 10 mg
Drug: LF-PB and Placebo
Other Name: extended-release of octreotide and placebo
Experimental: LF-PB 20 mg
2 IM injections = placebo + 20 mg
Drug: LF-PB and Placebo
Other Name: extended-release of octreotide and placebo
Experimental: LF-PB 30 mg
2 IM injections = 10 mg + 20 mg
Drug: LF-PB
Other Name: LF-PB 10 mg and LF-PB 20 mg
Placebo Comparator: Placebo
2 IM injections of placebo
Drug: Placebo
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female aged 18 to 80 years inclusive
  2. Body mass index (BMI) ≥18 kg/m2
  3. Signed informed consent form
  4. Diagnosis of BC
  5. Undergoing breast surgery with ALND Note: Collagen powder or fibrin sealant are not permitted.
  6. Negative serum pregnancy test for women of childbearing potential Note: Female patients of child-bearing potential should be advised to use adequate contraception if necessary during treatment with octreotide.
  7. AST and alanine aminotransferase ALT <1.5 x the upper limit of normal
  8. Ability to fully understand all study procedures and to comply with study visits scheduled for the duration of the study.

Exclusion Criteria:

  1. Presence of any of the following conditions:

    1. Previous axillary surgery on the same armpit undergoing surgery in this study
    2. Previous chemotherapy or radiotherapy within five years from study drug administration
    3. Previous neoadjuvant therapy
    4. Recurrent BC on the same breast undergoing surgery in this study
    5. Diabetes
    6. Cholelithiasis
    7. Hypothyroidism. If patient is being administered Euritox/ Levothyroxine (or analogues) and levels of T3, T4 and TSH are confirmed to be within the normal ranges at screening, the patient can be enrolled in this study.
    8. Hepatitis
    9. Pregnant or lactating
    10. Human immunodeficiency virus or hepatitis B or C by screening serology
  2. History of radiotherapy on the same breast or armpit undergoing surgery in this study.
  3. History of anaphylaxis to study drug
  4. Ascertained or presumptive hypersensitivity to the active principle and/or the ingredients of the study drug formulation
  5. QTc interval extension at screening or baseline > 450 msec (as the mean of 3 consecutive readings 5 minutes apart)
  6. Presence of any disease or use of concomitant medication known to increase the QT interval (see Appendix 2 for a list of such compounds)
  7. Clinically significant or relevant abnormal medical history, vital sign, physical examination, ECG, or laboratory evaluation finding
  8. Current or recurrent disease that could affect the results of the clinical or laboratory assessments required for the 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: NCT01754285

Locations
Italy
Humanitas Centro Catanese di Oncologia Dipartimento di Oncologia -Chirurgia Oncologica Generale
Via V.E. Dabormida, 64, Catania, Italy, 95125
Fondazione per la Ricerca e la Cura dei Tumori "Tommaso Campanella" Unità Operativa Complessa CRR per il Counselling Genetico e le Terapie Innovative in Oncologia Medica
Viale Europa-Loc. Germaneto, Catanzaro, Italy, 88100
Azienda Ospedaliera OIRM Sant'Anna Dipartimento Funzionale di Oncologia - Breast Unit
Corso Spezia, 60 Torino, Italy, 10126
IRCCS Azienda Ospedaliero Universitaria San Martino di Genova - IST Genova Dipartimento Chirurgia Ospedaliera - Semeiotica Chirurgica e Chirurgia Senologica
L.go Rosanna Benzi,10 Genova, Italy, 16132
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Chirurgia Generale Universitaria "G.Marinaccio"
Piazza Giulio Cesare 11 Bari, Italy, 70124
Azienda Ospedaliero-Universitaria Di Pisa
Pisa, Italy, 56123
Universita` Campus Bio-medico di Roma
Roma, Italy, 00128
Ospedale Casa Sollievo della Sofferenza - Istituto di Ricovero e Cura a Carattere Scientifico Opera di San Pio da Pietrelcina
San Giovanni Rotondo, Italy, 71013
Fondazione del Piemonte per l'Oncologia - IRCC Candiolo D.O. di Ginecologia Oncologica
Strada Provinciale 142 Km 3.95- Candiolo, Italy, 10060
Azienda Ospedaliero-Universitaria di Parma Dipartimento Clinica Chirurgica e Terapia Chirurgica
Via Gramsci, 14 Parma, Italy, 43126
IRCCS Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione Giovanni Pascale Dipartimento di Senologia - Struttura Complessa Oncologia Medica Senologica
Via Mariano Semmola Napoli, Italy, 80131
Azienda Ospedaliero Universitaria Policlinico di Modena Unità Semplice di Senologia
Via Pozzo 71, Modena, Italy, 41124
Azienda Ospedaliero Universitaria di Ferrara c/o Ospedale di Cona Sezione di Clinica Chirurgica
Vial Aldo Moro 8, Cona-Ferrara, Italy, 44124
Sponsors and Collaborators
Chemi S.p.A.
Investigators
Principal Investigator: Paolo Carcoforo, MD Clinica Chirurgica, Azienda Ospedaliero-Universitaria Arcispedale "S. Anna" Ferrara
  More Information

No publications provided

Responsible Party: Chemi S.p.A.
ClinicalTrials.gov Identifier: NCT01754285     History of Changes
Other Study ID Numbers: LF-PB/11/04
Study First Received: December 12, 2012
Last Updated: July 28, 2014
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Octreotide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014