Non-transitional cell carcinoma of the bladder and the urinary tract MedDRA version: 16.1 Level: LLT Classification code 10064467 Term: Urothelial carcinoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Paclitaxel
Product Name: Paclitaxel
Product Code: Paclitaxel
Pharmaceutical Form: Powder for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concentration unit: mg/m2 milli
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Exclusive or predominant presence of histologically confirmed diagnosis of non transitional cell tumors of the bladder or the urinary tract. • Locally advanced (defined as either T3bN0, T4N0, or anyTN+) or metastatic disease. • Age 18-75. • ECOG Performance Status 0-1. • Life expectancy of at least 12 weeks. • Written informed consent. • Measurable disease, defined as = 1 unidimensionally measurable lesion = 2 cm by conventional techniques or = 1 cm by spiral CT scan. • Patients must be accessible for treatment and follow up as well as they must be willing and capable to comply with the requirements of the study. Patients registered on this trial must be treated and followed at the participating center. • Adequate bone marrow, liver renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening. • No prior systemic chemotherapy (patients who received intravesical therapy for superficial disease will be eligible). • Relapse after more than 6 months of any perioperative treatment (for neoadjuvant or adjuvant purposes) is acceptable. • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: History of any one or more of the following cardiovascular conditions within the past 6 months: o Cardiac angioplasty or stenting. o Myocardial infarction. o Unstable angina. o Coronary artery by-pass graft surgery. o Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA). o Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted). • Clerance of creatinine less than 45 ml/min. • Patients undergoing renal dialysis. • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma or any cancer curatively treated > 5 years prior to study entry. • Women of child-bearing potential, who are biologically able to conceive, and not employing 2 forms of highly effective contraception. Women of child-bearing potential, defined as sexually mature women who have not undergone hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months must have a negative serum pregnancy test =14 days prior to start investigational drug. In instances where positive serum pregnancy test is suspected, transvaginal ultrasound and serial ßHCG monitoring must also be negative to rule out pregnancy. • Fertile males not willing to use a highly effective method of contraception or whose female partner is not using a highly effective contraception protection. • Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results. • Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer. • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug. • Prior perioperative treatment within 6 months of the date of study screening. • ECOG-Performance status = 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study will be to determine the activity of paclitaxel, ifosfamide, and cisplatin (TIP) (or carboplatin) in patients with non-transitional cell carcinoma of the bladder and the urinary tract.;Secondary Objective: The secondary objectives of this study are to: • To evaluate the safety and tolerability of TIP in a population of chemotherapy naive patients with non TCC of the bladder and urinary tract. • To evaluate translational correlates of response and outcome.;Primary end point(s): Progression-free survival (PFS).;Timepoint(s) of evaluation of this end point: Progression Free Survival (PFS) will be defined as the interval from the first dose of study drug to the date of the first documented disease progression or death for any reason. For the study purposes, the progression free survival rate at the time point of 6 months will be applied. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Incidence, nature and severity of treatment-related adverse events graded according to Common Terminology Criteria for Adverse Events v4.0. • Assessment of response-rate (RR) by RECIST v1.1 criteria. RR (%) = CR + PR. • Rate of pathologic complete responses (for patients undergoing surgery of residuals after TIP). • Overall Survival. • Correlation of PET response with CT response (RECIST) and with PFS. • Quality of life changes according to ESAS score and translational endpoints.;Timepoint(s) of evaluation of this end point: Patient accrual is expected to be completed within 33 months. Additional 6 months of follow up will be added up. | — |
Countries
Italy
Contacts
Public ContactPatrizia Giannatempo
Fondazione IRCCS Istituto Nazionale dei Tumori
Outcome results
None listed