ADVANCED OVARIAN CANCER MedDRA version: 21.1 Level: PT Classification code 10054913 Term: Serous cystadenocarcinoma ovary System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Letrozolo
Product Code: [L02BG04]
Pharmaceutical Form: Tablet
INN or Proposed INN: Letrozolo
CAS Number: 112809-51-5
Current Sponsor code: CGS 20267
Concentration unit: µg microgram(s)
C
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
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 platinum-based therapy or with last relapse occurred 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 10.0 g/dl ¬ Absolute neutrophil count 1.5 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 ¬ Bilirubin = 1.5 times the upper limit of normal (ULN) Estimated glomerular filtration 60mL/min • 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 56
Exclusion criteria
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 Bone Mineral Density(BMD) 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. • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Proportion of patient alive at 12 months;Secondary Objective: PFS OS ORR (according to RECIST criteria version 1.1) TPST TSST Toxicity profile (evaluated according to NCI-CTCAE version 4.0) Quality of Life (QoL) (evaluated by EORTC QLQ-C30/ QLQ-OV28 questionnaire, FACT Ovarian Symptom Index (FOSI), FACT-ES and Activity daily living (ADL) and instrumental ADL (IADL) scales);Primary end point(s): Proportion of patient alive at 12 months;Timepoint(s) of evaluation of this end point: 30 months | — |
Countries
Italy
Contacts
Public ContactDirezione Scientifica IRCCS
Margherita Zona
Outcome results
None listed