Exemestane in Hormone Receptor Positive High Grade Ovarian Cancer

NCT04460807 | Terminated Phase 3 DMC

• 2 other identifiers: 56UCS20172018-000693-30
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 47

Brief Summary

In this Italian, multicenter, randomized, double-blind, placebo controlled, phase III study the efficacy of exemestane will be evaluated in addition to the standard front line treatment in patients with hormone-receptor-positive high grade serous or endometrioid Epithelian Ovarian Cancer (EOC). The patients enrolled in the EXPERT trial will receive exemestane or placebo in addition to standard treatment. Patients and investigators will be blinded to study treatment. The hypothesis underlying the proposed clinical trial is that exemestane added to standard first line therapy will significantly prolong median progression free survival (PFS).

Conditions

Ovarian Cancer

Keywords

exemestane; aromatase inhibitors; clinical trial, phase 3; receptors, estrogen; receptors, progesterone

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  PFS id defined for each patient as the time from the date of randomization to the date of local or regional relapse, distant metastasis, second primary malignancy or death from any cause, whichever comes first. Patients not recurred, progressed or died while on study or lost to follow-up will be censored at their last disease assessment date.

  Up to 20 months

Secondary Outcomes (7)

• Overall survival (OS)

  Up to 20 months

• Objective Response Rate (ORR)

  a CT-scan will be performed every 4 months. Up to 20 months from last patients randomized

• Quality of Life: Menopause Quality of Life (MENQoL) questionnaire

  Up to 20 months

• Compliance - Number of administered cycles

  Up to 20 months

• Compliance - Reasons for discontinuation and treatment modification

  Up to 20 months

Other Outcomes (1)

• Circulating and tissue biomarkers

  Up to 20 months

Study Arms (2)

Exemestane

EXPERIMENTAL

Standard chemotherapy: paclitaxel 175 mg/m2 + carboplatin AUC 5, on day 1 every 21 days ± bevacizumab 15mg/kg, on day 1 every 21 days. Chemotherapy will be administered for 6 cycles; Bevacizumab will be administered as up to a maximum of 22 cycles. Patients unfit for standard treatment can receive a weekly schedule of treatment or monotherapy with carboplatin alone. Neoadjuvant chemotherapy is allowed in patients unfit for primary elective surgery. \+ Exemestane: single oral tablet of 25 mg/day until disease progression, unacceptable toxicity or physician/patient decision to withdraw, whichever comes first.

Drug: Exemestane

Placebo

PLACEBO COMPARATOR

Standard chemotherapy : paclitaxel 175 mg/m2 + carboplatin AUC 5, on day 1 every 21 days ± bevacizumab 15mg/kg, on day 1 every 21 days. Chemotherapy will be administered for 6 cycles; Bevacizumab will be administered as up to a maximum of 22 cycles. Patients unfit for standard treatment can receive a weekly schedule of treatment or monotherapy with carboplatin alone. Neoadjuvant chemotherapy is allowed in patients unfit for primary elective surgery. \+ Placebo: single oral tablet until disease progression, unacceptable toxicity or physician/patient decision to withdraw, whichever comes first.

Other: Placebo oral tablet

Interventions

Exemestane DRUG

Exemestane in addition to standard therapy, in Experimental arm.

Also known as: Mestane

Exemestane

Placebo oral tablet OTHER

Placebo in addition to standard therapy, in Control arm.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Citologically or histologically confirmed high grade serous or endometrial epithelial ovarian cancer, including cancer of fallopian tube and peritoneum. For patients who are candidates for neoadjuvant chemotherapy, diagnosis must be documented via imaging or a core tissue (not fine needle aspiration) biopsy.
• Disease stage IIB to IV according to FIGO classification. For patients who are candidates for neoadjuvant chemotherapy, stage IIB-IV should be documented via imaging or a core tissue (not fine needle aspiration) biopsy.
• Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy. For patients enrolling after debulking surgery, randomization should occur at a maximum of 12 weeks and not before 4 weeks after surgery.
• Immunoistochemically determined positivity (≥ 10%) for Progesterone and/or Estrogen receptor expression, including determination on cytology smears from ascitic fluid if surgery is differed.
• Measurable or evaluable disease confirmed by radiological imaging, or histological proven ovarian cancer in the absence of postoperatively measurable or evaluable lesions
• Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-2.
• Written, informed consent obtained prior to any study-specific procedures.

You may not qualify if:

• Previous systemic therapy for ovarian cancer.
• Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
• Inadequate bone marrow, hepatic or renal functions, assessed within 7 days prior to randomization.
• Treatment with hormonal contraceptives during the previous 3 months from diagnosis.
• Concurrent comorbidities, which contraindicates the administration of chemotherapy, or endocrine therapy.
• Pregnant or lactating patients.
• Inability or unwillingness to swallow tablets.

Sponsors & Collaborators

• Ente Ospedaliero Ospedali Galliera: lead
• Istituto Di Ricerche Farmacologiche Mario Negri: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator
• Federation of Italian Cooperative Oncology Groups: collaborator

Study Sites (47)

AO SS Antonio e Biagio e Cesare Arrigo

Alessandria, AL, Italy

Location

Ospedale Oncologico IRCCS Bari

Bari, BA, Italy

Location

Ospedale degli Infermi

Biella, BI, Italy

Location

AULSS 1 Dolomiti - Ospedale "Santa Maria del Prato"

Feltre, BL, Italy

Location

Azienda Ospedaliero Universitaria Policlinico S.Orsola-Malpighi

Bologna, BO, Italy

Location

ASST degli Spedali Civili di Brescia

Brescia, BS, Italy

Location

Fondazione Poliambulanza

Brescia, BS, Italy

Location

Ospedale di Manerbio

Manerbio, BS, Italy

Location

AOU Cagliari, Policlinico Universitario

Cagliari, CA, Italy

Location

Ospedale Policlinico "SS. Annunziata"

Chieti, CH, Italy

Location

Azienda Sanitaria Locale CN2

Alba, CN, Italy

Location

Azienda Ospedaliera S.Croce e Carle

Cuneo, CN, Italy

Location

Ospedale di Mondovì CN1

Mondovì, CN, Italy

Location

Ospedale Sant Anna di Como

Como, CO, Italy

Location

ARNAS Garibaldi

Catania, CT, Italy

Location

Azienda Ospedaliera per l'emergenza Cannizzaro

Catania, CT, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

Meldola, FC, Italy

Location

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, FG, Italy

Location

ASL 3 Ospedale Villa Scassi

Genova, GE, Italy

Location

IRCCS AOU San Martino - IST

Genova, GE, Italy

Location

ASST Lecco - Ospedale "A. Manzoni"

Lecco, LC, Italy

Location

Ospedale "Vito Fazzi"

Lecce, LE, Italy

Location

UOS Oncologia Ginecologica, Ospedale S. Gerardo

Monza, MB, Italy

Location

Presidio Ospedaliero Unico Av3

Macerata, MC, Italy

Location

Istituto Europeo di Oncologia (IEO)

Milan, MI, Italy

Location

AOU Policlinico di Modena

Modena, MO, Italy

Location

A.R.N.A.S. Ospedali Civico Di Cristina Benfratelli

Palermo, PA, Italy

Location

Ospedale "Guglielmo da Saliceto"

Piacenza, PC, Italy

Location

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, Italy

Location

CRO Centro di Riferimento Oncologico

Aviano, PN, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, PV, Italy

Location

Azienda Ospedaliera Regionale San Carlo

Potenza, PZ, Italy

Location

Ospedale "degli Infermi"

Faenza, RA, Italy

Location

Ospedale "Umberto I"

Lugo, RA, Italy

Location

Ospedale Santa Maria delle Croci

Ravenna, RA, Italy

Location

Azienda Ospedaliera Arcispedale Santa Maria Nuova

Reggio Emilia, RE, Italy

Location

Policlinico Umberto I, Università di Roma "La Sapienza"

Roma, RM, Italy

Location

Policlinico Universitario Fondazione Agostino Gemelli

Roma, RM, Italy

Location

ASST Valtellina e Alto Lario

Sondrio, SO, Italy

Location

Azienda Ospedaliero Universitaria di Sassari

Sassari, SS, Italy

Location

Fondazione del Piemonte per l'Oncologia - IRCCS

Candiolo, TO, Italy

Location

AO Ordine Mauriziano

Torino, TO, Italy

Location

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza - Ospedale Ostetrico Ginecologico Sant'Anna

Torino, TO, Italy

Location

Presidio Ospedaliero S. Andrea

Vercelli, VC, Italy

Location

Medical Oncology Division, Ente Ospedaliero Ospedali Galliera

Genova, 16128, Italy

Location

Istituto Nazionale Tumori - IRCCS "Fondazione G.Pascale"

Napoli, Italy

Location

Azienda Ospedaliero-Universitaria Maggiore della Carità

Novara, Italy

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

exemestane

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Andrea DeCensi

  E.O. Ospedali Galliera Genova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: July 8, 2020
• Study Start: February 13, 2020
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be shared 3 months following the publication of the article and they will remain available for 36 months.
• Access Criteria: the investigators who would like to use the data have to prepare a proposal that needs to be approved the Steering committee. The aim of the access to study data needs to be specified in the proposal. Proposals should be sent to the Principal investigator (andrea.decensi@galliera.it). To gain access, data requestors will need to sign a data access agreement.

Locations

IT (47)