Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE3
Total Enrollment
86 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-06-22
Study Completion Date
2024-11-04
Brief Summary
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Randomized phase III multicenter study investigating the role of letrozole in heavily pretreated recurrent ovarian cancer.
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Detailed Description
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This is a randomized, open-label, phase III, multicenter, global study evaluating the efficacy and safety of Letrozole in heavily pretreated recurrent ovarian cancer patients in comparison to physician' choice chemotherapy.
Subjects who meet all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two arms, as follow:
Arm A: Letrozole 1 tablet (2,5 mg) orally once a day in 28-day cycles Arm B: Pegylated Liposomal Doxorubicin 40 mg/m2 d1q28 or Topotecan 4 mg/m2 d1,8,15q28 or Gemcitabine 1000 mg/m2 d1,8,15q28 or Paclitaxel 80 mg/m2 d1,8,15q28 In case of objective response and acceptable toxicity, no maximum number of cycles of treatment is defined.
The aim of the study is to assess the activity of Letrozole in women with recurrent epithelial ovarian cancer, heavily pretreated.
Subjects who meet all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two arms, as follow:
Arm A: Letrozole 1 tablet (2,5 mg) orally once a day in 28-day cycles Arm B: Pegylated Liposomal Doxorubicin 40 mg/m2 d1q28 or Topotecan 4 mg/m2 d1,8,15q28 or Gemcitabine 1000 mg/m2 d1,8,15q28 or Paclitaxel 80 mg/m2 d1,8,15q28 In case of objective response and acceptable toxicity, no maximum number of cycles of treatment is defined.
The aim of the study is to assess the activity of Letrozole in women with recurrent epithelial ovarian cancer, heavily pretreated.
Conditions
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Epithelial Ovarian Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
This is a two arms, prospective, open-label multi center randomized phase III study.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Letrozole
Letrozole 1 tablet (2,5 mg) orally once a day
Group Type
EXPERIMENTAL
Letrozole 2.5mg
Intervention Type
DRUG
This study will investigate the role of Letrozole in patients affected by heavily pretreated platinum resistant ovarian cancer, compared to standard treatment.
Standard Chemotherapy
Either Paclitaxel 80 mg/m2 as a 1-h infusion, on days 1,8,15,22 every 28 days or Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 given every 4 weeks or Topotecan 4mg/m2 IV on days 1,8,15 every 4 weeks or Gemcitabine 1000 mg/m2 IV over 30 min on days 1,8,15 every 28 days.
Group Type
ACTIVE_COMPARATOR
Standard single agent chemotherapy
Intervention Type
DRUG
Either Paclitaxel 80 mg/m2 as a 1-h infusion, on days 1,8,15,22 every 28 days or Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 given every 4 weeks or Topotecan 4mg/m2 IV on days 1,8,15 every 4 weeks or Gemcitabine 1000 mg/m2 IV over 30 min on days 1,8,15 every 28 days.
Interventions
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Letrozole 2.5mg
This study will investigate the role of Letrozole in patients affected by heavily pretreated platinum resistant ovarian cancer, compared to standard treatment.
Intervention Type
DRUG
Standard single agent chemotherapy
Either Paclitaxel 80 mg/m2 as a 1-h infusion, on days 1,8,15,22 every 28 days or Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 given every 4 weeks or Topotecan 4mg/m2 IV on days 1,8,15 every 4 weeks or Gemcitabine 1000 mg/m2 IV over 30 min on days 1,8,15 every 28 days.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Female of 18 years of age or older
* Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
* Platinum resistant or refractory disease (patients who did not respond to last platinumbased therapy or with last relapse occurred \< 6 months from the last dose of platinum) or patients not amenable of platinum treatment
* \>3 previous chemotherapy lines
* ECOG performance status 0 -2
* Measurable and evaluable disease according to RECIST criteria confirmed by radiological imaging: at least one lesion of ≥ 1.0 cm for non-lymph nodes or ≥ 1.5 cm in short-axis diameter for lymph nodes at CT scan (Subjects with isolated rising CA-125 without radiologically visible disease are excluded)
* Left Ventricular Ejection Fraction (LVEF) ≥ institutional lower limit normal
* Estimated life expectancy ≥ 16 weeks
* Adequate functions evidenced by:
* Hemoglobin ³10.0 g/dl
* Absolute neutrophil count ³1.5 x 109/L
* White blood cells \>3x109/L
* Platelet \>100 x109/L
* AST and ALT £ 2.5 x Upper limit of normal, unless liver metastasis, in which case AST and ALT \< or = 5 x Upper limit of normal will be accepted
* Bilirubin ≤ 1.5 times the upper limit of normal (ULN)
* Estimated glomerular filtration ³ 60mL/min using the Cockcroft-Gault equation.
* Patient able to comply with the treatment
* Evidence of not pregnancy status as documented by a negative beta-human chorionic gonadotropin (ß-hCG) test
* Not breastfeeding women
* Patients with child-bearing potential using (or willing to use) effective contraception during treatment and 3 months ahead unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically.
* Comprehension and signature of the informed consent
* Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
* Platinum resistant or refractory disease (patients who did not respond to last platinumbased therapy or with last relapse occurred \< 6 months from the last dose of platinum) or patients not amenable of platinum treatment
* \>3 previous chemotherapy lines
* ECOG performance status 0 -2
* Measurable and evaluable disease according to RECIST criteria confirmed by radiological imaging: at least one lesion of ≥ 1.0 cm for non-lymph nodes or ≥ 1.5 cm in short-axis diameter for lymph nodes at CT scan (Subjects with isolated rising CA-125 without radiologically visible disease are excluded)
* Left Ventricular Ejection Fraction (LVEF) ≥ institutional lower limit normal
* Estimated life expectancy ≥ 16 weeks
* Adequate functions evidenced by:
* Hemoglobin ³10.0 g/dl
* Absolute neutrophil count ³1.5 x 109/L
* White blood cells \>3x109/L
* Platelet \>100 x109/L
* AST and ALT £ 2.5 x Upper limit of normal, unless liver metastasis, in which case AST and ALT \< or = 5 x Upper limit of normal will be accepted
* Bilirubin ≤ 1.5 times the upper limit of normal (ULN)
* Estimated glomerular filtration ³ 60mL/min using the Cockcroft-Gault equation.
* Patient able to comply with the treatment
* Evidence of not pregnancy status as documented by a negative beta-human chorionic gonadotropin (ß-hCG) test
* Not breastfeeding women
* Patients with child-bearing potential using (or willing to use) effective contraception during treatment and 3 months ahead unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically.
* Comprehension and signature of the informed consent
Exclusion Criteria
* Subjects with borderline ovarian cancer
* Subject with low malignant potential tumors
* Less than 3 lines of previous therapies
* Platinum sensitive disease (last relapse occurred \> 6 months from the last dose of platinum)
* Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy
* History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 3 years or longer
* Breastfeeding women
* Pregnant women
* Prior therapy with letrozole.
* Severe osteoporosis documented by BMD (Bone Mineral Density) T-score ≤ -2.5 with existing fragility fracture(s)
* Patients with a known hypersensitivity to Paclitaxel , PLD, Topotecan, Gemcitabine or Letrozole or any case of severe toxicity related to them. Also Patients with a known hypersensitivity to any of the ingredients or excipients of the IMPs (e.g. macrogolglycerol ricinoleate (polyoxyl castor oil), ethanol, anhydrous, citric acid, anhydrous, sodium chloride hydrochloric acid, mannitol, sodium acetate, sodium hydroxide, tartaric acid, lactose monohydrate, maize starch, hypromellose Type 2910, cellulose microcrystalline, sodium starch glycolate type A, colloidal anhydrous silica, magnesium stearate, hypromellose 6 cp E464, titanium dioxide E171, Iron oxide yellow E172, Macrogol 400, talc E553b)
* Prior resistance to Paclitaxel, PLD, Topotecan, Gemcitabine
* Patients with active hepatic disease (HCV or HBV infections), hepatic severe impairment or cirrhosis
* Bowel obstruction, sub-occlusive disease, prior gastrectomy, symptomatic brain metastases.
* Myocardial infarct within six months before enrolment , NYHA Class II or worse heart failure, unstable angina, serious cardiac arrhythmia or cardiac arrhythmia requiring treatment.
* Any serious concomitant illness requiring treatment
* Pre-existing peripheral neuropathy \> CTCAE Grade 2.
* Concomitant use of strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, and telithromycin) or strong CYP2A6 inhibitors (e.g. methoxsalen) because they may increase exposure to letrozole.
* Concomitant use of inducers of CYP3A4 (e.g. phenytoin, rifampicin, carbamazepine, phenobarbital, and St. John's Wort) which may reduce exposure to letrozole.
* Concomitant use of medicinal products with a narrow therapeutic index that are substrates for CYP2C19 (e.g. phenytoin, clopidrogel) that may have their systemic serum concentrations altered by letrozole.
* Subject with low malignant potential tumors
* Less than 3 lines of previous therapies
* Platinum sensitive disease (last relapse occurred \> 6 months from the last dose of platinum)
* Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy
* History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 3 years or longer
* Breastfeeding women
* Pregnant women
* Prior therapy with letrozole.
* Severe osteoporosis documented by BMD (Bone Mineral Density) T-score ≤ -2.5 with existing fragility fracture(s)
* Patients with a known hypersensitivity to Paclitaxel , PLD, Topotecan, Gemcitabine or Letrozole or any case of severe toxicity related to them. Also Patients with a known hypersensitivity to any of the ingredients or excipients of the IMPs (e.g. macrogolglycerol ricinoleate (polyoxyl castor oil), ethanol, anhydrous, citric acid, anhydrous, sodium chloride hydrochloric acid, mannitol, sodium acetate, sodium hydroxide, tartaric acid, lactose monohydrate, maize starch, hypromellose Type 2910, cellulose microcrystalline, sodium starch glycolate type A, colloidal anhydrous silica, magnesium stearate, hypromellose 6 cp E464, titanium dioxide E171, Iron oxide yellow E172, Macrogol 400, talc E553b)
* Prior resistance to Paclitaxel, PLD, Topotecan, Gemcitabine
* Patients with active hepatic disease (HCV or HBV infections), hepatic severe impairment or cirrhosis
* Bowel obstruction, sub-occlusive disease, prior gastrectomy, symptomatic brain metastases.
* Myocardial infarct within six months before enrolment , NYHA Class II or worse heart failure, unstable angina, serious cardiac arrhythmia or cardiac arrhythmia requiring treatment.
* Any serious concomitant illness requiring treatment
* Pre-existing peripheral neuropathy \> CTCAE Grade 2.
* Concomitant use of strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, and telithromycin) or strong CYP2A6 inhibitors (e.g. methoxsalen) because they may increase exposure to letrozole.
* Concomitant use of inducers of CYP3A4 (e.g. phenytoin, rifampicin, carbamazepine, phenobarbital, and St. John's Wort) which may reduce exposure to letrozole.
* Concomitant use of medicinal products with a narrow therapeutic index that are substrates for CYP2C19 (e.g. phenytoin, clopidrogel) that may have their systemic serum concentrations altered by letrozole.
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Sponsor Role
lead
Responsible Party
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MARCHETTI CLAUDIA
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Claudia Marchetti
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Locations
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DH Tumori Femminili
Roma, , Italy
Site Status
Countries
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Italy
References
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Other Identifiers
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MITO32
Identifier Type: -
Identifier Source: org_study_id
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NCT00634894
WITHDRAWN
PHASE2
A Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of RO6870810 and Atezolizumab (PD-L1 Antibody) in Participants With Advanced Ovarian Cancer or Triple Negative Breast Cancer
NCT03292172
TERMINATED
PHASE1
Ribociclib and Letrozole Treatment in Ovarian Cancer
NCT03673124
ACTIVE_NOT_RECRUITING
PHASE2
A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Relapsed Ovarian Cancer
NCT04718376
TERMINATED
PHASE1
Study of OSI-211 vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer
NCT00046800
COMPLETED
PHASE2
Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer
NCT06535334
NOT_YET_RECRUITING
Exemestane in Hormone Receptor Positive High Grade Ovarian Cancer
NCT04460807
TERMINATED
PHASE3
A Study of Apatinib Combined With Letrozole With or Without Fluzoparib in Estrogen Receptor-Positive, Platinum-Sensitive Recurrent Ovarian Cancer Previously Treated With First-Line PARP Inhibitor
NCT07000344
NOT_YET_RECRUITING
NA
Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer
NCT00170677
COMPLETED
PHASE2