Bladder Cancer Urothelial Cancer
Conditions
Interventions
50% of the patients receive 3-weekly cycles of intravenous cabazitaxel, the
other 50% of the patients receive 3-weekly cycles of intravenous vinflunine.
Sponsors
Associació Per a la Recerca Oncològica (APRO)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) The patient has given written informed consent stating that he or she understands the purpose of the study and the procedures involved and agrees to participate in the study. 2) The patient has histologically confirmed TCCU (urinary bladder, urethra, ureter or renal pelvis). Patients with mixed histology may be enrolled if transitional cell carcinoma is the predominant component (i.e., > 50% of the histopathology sample), with the exception of neuroendocrine or small cell carcinoma. 3) The patient has advanced disease defined as a locally advanced tumour considered to be unresectable (T4b), node involvement in the inguinal area or above the aortic bifurcation (that are considered to be distant nodes and so metastasis) or metastasis in distant organs. 4) The patient should have received one prior platinum-based chemotherapy treatment for locally advanced or stage IV TCCU. Prior platinum-based adjuvant or neoadjuvant therapy is allowed if more than 6 months have elapsed since the end of adjuvant or neoadjuvant therapy till tumour relapse. 5) The patient has at least one measurable tumour lesion (measurable disease, as defined by the RECIST criteria v1.1), for the phase II part of the study. If all sites of measurable disease have been irradiated, one site must have demonstrated growth after irradiation. For phase III part, patients with only non measurable disease are allowed for enrolment. 6) Age >=18 years. 7) ECOG PS 0 or 1. 8) The patient may have no more than ONE of the following unfavourable risk factors: a) haemoglobin =100 x109/L b) Absolute neutrophil count (ANC) >1.5x109/L c) Serum creatinine
Exclusion criteria
Exclusion criteria: 1) Patients that have 2 or more of the following unfavourable risk factors: a) Haemoglobin 1 (NCI-CTCAE, Version 4.0) from previous anti-cancer therapy (other than alopecia). 4) Patients who had undergone major surgery, radiation therapy or treatment with chemotherapy or any investigational agent within 28 days prior to Study day 1. 5) Evidence of severe or uncontrolled systemic disease or any concurrent condition (including uncontrolled diabetes mellitus) which in the Investigator*s opinion makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the protocol. 6) History of another neoplasm. Patients with prior history of either non-metastatic non-melanoma skin cancers; carcinoma in situ of the cervix; or cancer cured by surgery, small field radiation or chemotherapy >=3 years prior to randomisation; or treated patients with early stage and low risk prostate cancer (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II part · ORR, which includes the sum of the complete and partial responses (CR+PR), (according to Response Evaluation Criteria in Solid Tumours [RECIST criteria v1.1]). Phase III part: · OS defined as the time from randomisation to death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II part · PFS defined as the time from randomisation to either documented disease progression or death from any cause (whichever occurs earlier) · OS · Adverse events (AEs) will be coded and evaluated using the National Cancer Institute, Common Toxicity criteria for Adverse Events (NCI-CTCAE) v4.0 toxicity criteria (if NCI-CTCAE are not applicable, the Medical Dictionary for Regulatory Activities [MedDRA] will be used). Phase III part: · Secondary endpoints: · ORR (RECIST criteria v1.1). · PFS · AEs (according to NCI-CTCAE v4.0 toxicity criteria). | — |
Countries
Netherlands
Outcome results
None listed