Clinical trial NCT01754285: Extended-release of Octreotide (LF-PB) for the Treatment of Lymphorrhea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphorrhea
Lead sponsor: Chemi S.p.A.
Sponsor class: INDUSTRY
First posted: 2012-12-21
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: effect of LF-PB 10 mg, 20 mg, and 30 mg on time to resolution of lymphorrhea;
timeFrame: 12 weeks post surgery
measure: number of AEs and laboratory, ECG, vital sign abnormalities of LF-PB 10 mg, 20 mg, and 30 mg
timeFrame: 12 weeks after surgery
Secondary outcomes:
measure: effects of LF-PB 10, 20, and 30 mg on the daily volume of lymph collected from the drain
timeFrame: 12 weeks after surgery
measure: number of complications related to lymphorrhea
timeFrame: 12 weeks after surgery
measure: PK profile (Cmax, Tmax, AUC0-t and possibly AUC0-inf and T1/2) of LF-PB 10, 20 and 30 mg
timeFrame: 12 weeks after surgery
Other outcomes:
measure: correlation between LF-PB exposures and efficacy after the administration of LF-PB 10 mg, 20 mg, and 30 mg
timeFrame: 12 weeks after surgery
Locations:
city: Via V.E. Dabormida, 64
country: Italy
facility: Humanitas Centro Catanese di Oncologia Dipartimento di Oncologia -Chirurgia Oncologica Generale
state: Catania
city: Viale Europa-Loc. Germaneto
country: Italy
facility: 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
state: Catanzaro
city: Corso Spezia, 60 Torino
country: Italy
facility: Azienda Ospedaliera OIRM Sant'Anna Dipartimento Funzionale di Oncologia - Breast Unit
city: L.go Rosanna Benzi,10 Genova
country: Italy
facility: IRCCS Azienda Ospedaliero Universitaria San Martino di Genova - IST Genova Dipartimento Chirurgia Ospedaliera - Semeiotica Chirurgica e Chirurgia Senologica
city: Piazza Giulio Cesare 11 Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Chirurgia Generale Universitaria "G.Marinaccio"
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Di Pisa
city: Roma
country: Italy
facility: Universita' Campus Bio-medico di Roma
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza - Istituto di Ricovero e Cura a Carattere Scientifico Opera di San Pio da Pietrelcina
city: Strada Provinciale 142 Km 3.95- Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia - IRCC Candiolo D.O. di Ginecologia Oncologica
city: Via Gramsci, 14 Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma Dipartimento Clinica Chirurgica e Terapia Chirurgica
city: Via Mariano Semmola Napoli
country: Italy
facility: IRCCS Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione Giovanni Pascale Dipartimento di Senologia - Struttura Complessa Oncologia Medica Senologica
city: Via Pozzo 71, Modena
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico di Modena Unità Semplice di Senologia
city: Vial Aldo Moro 8, Cona-Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria di Ferrara c/o Ospedale di Cona Sezione di Clinica Chirurgica
Study officials:
affiliation: Clinica Chirurgica, Azienda Ospedaliero-Universitaria Arcispedale "S. Anna" Ferrara
name: Paolo Carcoforo, MD
role: PRINCIPAL_INVESTIGATOR
References: