Platinum-resistant ovarian cancer MedDRA version: 20.0 Level: LLT Classification code 10006888 Term: Ca ovary System Organ Class: 100000004864
Conditions
Interventions
Trade Name: PACLITAXEL MYLAN GENERICS - 6 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO DI VETRO DA 5 ML
Product Name: Paclitaxel
Product Code: [Paclitaxel]
Pharmaceutical Form: Solution
Sponsors
FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Cytologic / histologic diagnosis of stage IC-IV epithelial , fallopian tube and primary peritoneal cancer (carcinosarcomas are included) 2. Patient who received 1-2 prior lines of treatments 3. Patient relapsed within 6 months after platinum containing regimen 4. Disease measurable or evaluable by RECIST version 1.1 or Ca 125 GCIG criteria 5. No residual peripheral neurotoxicity > Grade 1 from previous chemotherapy treatment 6. PS 0-1 7. Age >18 years. 8. Life expectancy of at least 3 months 9. Written informed consent prior to performance of study specific procedures or assessments 10. Ability and willingness to comply with treatment and follow up assessments and procedures 11. Adequate organ functions: - Hematopoietic: Leukocytes > 2,500/mm3; Absolute neutrophil count >1,500/mm3; Platelets count >100,000/mm3; Hemoglobin >9 g/dL - Hepatic: AST and ALT 45 mL/min 12. No other invasive malignancy within the past 3 years except non-melanoma skin cancer and in situ cervical cancer 13. Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule. 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 99 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Pregnant (potentially fertile patients must use contraceptive measures to avoid pregnancy during and for at least 3 months after study participation and must have a negative serum pregnancy test at baseline). 2. Patients should not be breast-feeding during treatment and for 2 months following the end of treatment. 3. Serious heart disease, including heart failure, atrio-ventricular block of any degree, serious arrhythmia or history of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, coronary artery by-pass graft surgery, class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA) 4. Active infection requiring antibiotics. 5. History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months 6. History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C. 7. Patients who had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Subjects with < Grade 2 neuropathy or = Grade 2 alopecia are an exception to this criterion and may qualify for the study. 8. Patients with evidence of interstitial lung disease. 9. Major surgical procedure, open biopsy, or significant traumatic injury within 3 weeks prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedures such as fine needle aspiration or core biopsy within 1 week prior to beginning therapy are also excluded. 10. Known hypersensitivity to the study drugs or to drugs with similar chemical structures. 11. Concurrent treatment with other experimental drugs. 12. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the treatment groups in terms of progression free survival (PFS).;Secondary Objective: The secondary objectives are to compare the treatment groups in terms of: - Overall survival (OS) - Radiological response rate (in patients with measurable disease) - Duration of response - CA-125 response rate per GCIG and change in CA-125 - Toxicity profile - Quality of Life assessments using FACT-O and FACT-O ovarian;Primary end point(s): Progression free survival (PFS);Timepoint(s) of evaluation of this end point: PFS will be measured from the date of randomization to the date of radiological/clinical progression of desease or death (whichever occurs first). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall Survival (OS); Response Rate ; Patient reported outcome (PRO);Timepoint(s) of evaluation of this end point: The OS will be measured from the date of randomization to the date of death.; The Response Rate will be measured for the whole study duration.; Whole study duration | — |
Countries
Italy
Contacts
Public ContactClinical Trial Center
Fondazione IRCCS Istituto Nazionale Tumori
Outcome results
None listed