advanced or metastatic transitional cell carcinoma of the urothelium MedDRA version: 14.0 Level: LLT Classification code 10038498 Term: Renal pelvis and ureter transitional cell cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: JEVTANA 60 mg concentrado y disolvente para solución para perfusión.
Product Name: cabazitaxel
Pharmaceutical Form: Concentrate and diluent for solution for infusion
CAS Number: 183133-96-
Sponsors
Grupo Español de Tratamiento de Tumores Genitourinarios (SOGUG)-Spanish Genitourinary Oncologic Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed transitional carcinoma of the urothelium (bladder, urethra, ureter, or renal pelvis). Patients with mixed histology are eligible if transitional carcinoma is predominant component (i.e. >50% of the pathologic specimen). 2. One previous cisplatin-based chemotherapy (with a minimum of 4 cycles). a. Patients with unresectable locally advanced tumors or metastatic transitional cell tumors of the urothelium who have progressed or relapsed after a maximum of 12 months since the last course of cisplatin-based chemotherapy. b. Patients treated with adjuvant / neoadjuvant chemotherapy are eligible if their relapse occurs ?12 months after the last cisplatin course; in this case, adjuvant or neoadjuvant chemotherapy will be considered as the first line. c. Patients with stable or responding disease at the end of first-line therapy should be included only if they stabilization occurs after 6 cycles of chemotherapy. 3. Age ?18 years 4. Eastern Cooperative Oncology Group (ECOG) performance status of ?2. 5. Subjects must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. 6. At least one measurable lesion (RECIST criteria, Version 1.1). 7. At least 4 weeks and recovery from effects of the last chemotherapy course, prior surgery, prior radiotherapy, or other therapy with an approved or investigational agent. 8. Adequate hematologic, hepatic, and renal function: Hemoglobin ?9.0 g/dL (transfusion allowed), Platelet count ?100,000/?L, absolute neutrophil count > 1500/mm3, Serum creatinine 12 weeks. 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 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 105
Exclusion criteria
Exclusion criteria: Any patient who relapse after more than 12 months since the last chemotherapy course. Patients who have received more than one prior chemotherapeutic regimen. Adjuvant or neoadjuvant chemotherapy will be considered to have been first line (in this case, patients will be eligible only if progression occurs within 12 months of the last course). Tumors with neuroendocrine differentiation or small cell histology in any percentage of the specimen. Non cisplatinum regimen as first chemotherapy. Patients who received more than one cytotoxic chemotherapy regimen (either as adjuvant, neoadjuvant or metastatic treatment). Serious or uncontrolled coexistent nonmalignant disease, particularly active and uncontrolled infection. Neuropathy grade ? 2 (NCI CTC, Version 4.0), either post chemotherapy or secondary to a different disease (diabetes, etc.). Known metastasis or symptoms of metastasis to the central nervous system. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or left ventricular ejection fraction (LVEF) of <50% at baseline. Subjects with childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration. Pregnancy or lactancy. Condition or situation which, in the investigator?s opinion, may put the subjects at significant risk, may confound the study results, or may interfere significantly with subject?s participation in the study. Prior treatment with a taxane or other tubulin-targeted agent including a vinca alkaloid. Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of cabacitaxel as second line therapy for patients with tratnsitional cell tumors of the urothelium who have relapsed after a maximum 12 month since the last dose of a cisplatin-based chemotherapy, adjusting the result to the four prognostic subgroups describe in these setting.;Secondary Objective: To evaluate the efficacy of cabazitaxel separately in each subgroup. To describe the toxicity of cabazitaxel in this setting. To analyze QOL (optional). To validate prospectively the recently published prognostic classification for these patients, and to analyze the influence of time to progression to the first-line chemotherapy of ? 6 months vs 6 -12 months as an additional prognostic factor.;Primary end point(s): % of objective response ( RECIST v1.1).;Timepoint(s) of evaluation of this end point: every 3 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the efficacy of cabazitaxel separately in each subgroup. To describe the toxicity of cabazitaxel in this setting. To analyze QOL (optional). To validate prospectively the recently published prognostic classification for these patients, and to analyze the influence of time to progression to the first-line chemotherapy of ? 6 months vs 6 -12 months as an additional prognostic factor. | — |
Countries
Spain
Contacts
Public ContactPaz González
PIVOTAL S.L.
Outcome results
None listed