Status:
TERMINATED
Exemestane in Hormone Receptor Positive High Grade Ovarian Cancer
Lead Sponsor:
Ente Ospedaliero Ospedali Galliera
Collaborating Sponsors:
Istituto Di Ricerche Farmacologiche Mario Negri
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 wi...
Detailed Description
Estrogen and Progesterone play a role in promoting EOC growth, metastasis, and progression. Recent data show that ER and PgR expression is frequent in high grade EOC and has prognostic significance. A...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04460807
Start Date
February 13 2020
End Date
April 27 2023
Last Update
February 12 2024
Active Locations (47)
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1
AO SS Antonio e Biagio e Cesare Arrigo
Alessandria, AL, Italy
2
Ospedale Oncologico IRCCS Bari
Bari, BA, Italy
3
Ospedale degli Infermi
Biella, BI, Italy
4
AULSS 1 Dolomiti - Ospedale "Santa Maria del Prato"
Feltre, BL, Italy