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

NCT ID: NCT01754285

Last Updated: 2014-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-05-31

Brief Summary

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.

Conditions

Lymphorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

LF-PB 10 mg

2 IM injections = placebo + 10 mg

Group Type: EXPERIMENTAL

LF-PB and Placebo

Intervention Type: DRUG

LF-PB 20 mg

2 IM injections = placebo + 20 mg

Group Type: EXPERIMENTAL

LF-PB and Placebo

Intervention Type: DRUG

LF-PB 30 mg

2 IM injections = 10 mg + 20 mg

Group Type: EXPERIMENTAL

LF-PB

Intervention Type: DRUG

Placebo

2 IM injections of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

LF-PB and Placebo

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

LF-PB

Intervention Type: DRUG

Other Intervention Names

extended-release of octreotide and placebo; LF-PB 10 mg and LF-PB 20 mg

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chemi S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paolo Carcoforo, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Chirurgica, Azienda Ospedaliero-Universitaria Arcispedale "S. Anna" Ferrara

Locations

Humanitas Centro Catanese di Oncologia Dipartimento di Oncologia -Chirurgia Oncologica Generale

Via V.E. Dabormida, 64, Catania, Italy

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

Azienda Ospedaliera OIRM Sant'Anna Dipartimento Funzionale di Oncologia - Breast Unit

Corso Spezia, 60 Torino, , Italy

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

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Chirurgia Generale Universitaria "G.Marinaccio"

Piazza Giulio Cesare 11 Bari, , Italy

Azienda Ospedaliero-Universitaria Di Pisa

Pisa, , Italy

Universita' Campus Bio-medico di Roma

Roma, , Italy

Ospedale Casa Sollievo della Sofferenza - Istituto di Ricovero e Cura a Carattere Scientifico Opera di San Pio da Pietrelcina

San Giovanni Rotondo, , Italy

Fondazione del Piemonte per l'Oncologia - IRCC Candiolo D.O. di Ginecologia Oncologica

Strada Provinciale 142 Km 3.95- Candiolo, , Italy

Azienda Ospedaliero-Universitaria di Parma Dipartimento Clinica Chirurgica e Terapia Chirurgica

Via Gramsci, 14 Parma, , Italy

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

Azienda Ospedaliero Universitaria Policlinico di Modena Unità Semplice di Senologia

Via Pozzo 71, Modena, , Italy

Azienda Ospedaliero Universitaria di Ferrara c/o Ospedale di Cona Sezione di Clinica Chirurgica

Vial Aldo Moro 8, Cona-Ferrara, , Italy

Countries

Italy

Other Identifiers

LF-PB/11/04

Identifier Type: -

Identifier Source: org_study_id