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

Phase 2

Completed

• Conditions: Lymphorrhea
• Interventions: Drug: LF-PB; Drug: Placebo; Drug: LF-PB and Placebo

• Registration Number: NCT01754285
• Lead Sponsor: Chemi S.p.A.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-21
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-28
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LF-PB 30 mg	LF-PB	2 IM injections = 10 mg + 20 mg
Placebo	Placebo	2 IM injections of placebo
LF-PB 10 mg	LF-PB and Placebo	2 IM injections = placebo + 10 mg
LF-PB 20 mg	LF-PB and Placebo	2 IM injections = placebo + 20 mg

Primary Outcome Measures

Name	Time	Method
effect of LF-PB 10 mg, 20 mg, and 30 mg on time to resolution of lymphorrhea;	12 weeks post surgery	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	12 weeks after surgery	Safety and tolerability of LF-PB

Secondary Outcome Measures

Name	Time	Method
effects of LF-PB 10, 20, and 30 mg on the daily volume of lymph collected from the drain	12 weeks after surgery	daily volume of lymph collected from the drain
number of complications related to lymphorrhea	12 weeks after surgery	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	12 weeks after surgery	PK parameters

Trial Locations

Locations (13)

Ospedale Casa Sollievo della Sofferenza - Istituto di Ricovero e Cura a Carattere Scientifico Opera di San Pio da Pietrelcina; 🇮🇹 San Giovanni Rotondo, Italy

Humanitas Centro Catanese di Oncologia Dipartimento di Oncologia -Chirurgia Oncologica Generale; 🇮🇹 Via V.E. Dabormida, 64, Catania, Italy

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Chirurgia Generale Universitaria "G.Marinaccio"; 🇮🇹 Piazza Giulio Cesare 11 Bari, 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

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

Universita' Campus Bio-medico di Roma; 🇮🇹 Roma, 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 Di Pisa; 🇮🇹 Pisa, Italy

Azienda Ospedaliero Universitaria Policlinico di Modena Unità Semplice di Senologia; 🇮🇹 Via Pozzo 71, Modena, Italy

Azienda Ospedaliera OIRM Sant'Anna Dipartimento Funzionale di Oncologia - Breast Unit; 🇮🇹 Corso Spezia, 60 Torino, 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

Azienda Ospedaliero Universitaria di Ferrara c/o Ospedale di Cona Sezione di Clinica Chirurgica; 🇮🇹 Vial Aldo Moro 8, Cona-Ferrara, Italy