A phase II open label study of cabazitaxel in patients with advanced or metastatic transitional cell carcinoma of the urothelium who have progressed ?12 months after a previous platinum based chemotherapy

Active, not recruiting

• Conditions: advanced or metastatic transitional cell carcinoma of the urothelium; MedDRA version: 14.0Level: LLTClassification code 10038498Term: Renal pelvis and ureter transitional cell cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003498-27-ES
• Lead Sponsor: Grupo Español de Tratamiento de Tumores Genitourinarios (SOGUG)-Spanish Genitourinary Oncologic Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-28
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

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 <1.5 x upper limit of normal (ULN) or a calculated creatinine clearance ? 50
mL/min,
ALT, AST and bilirrubin < 1.5 x ULN (<5xULN if liver metastasis are present). In
patients with previously documented Glibert?s disease, the upper limit of serum bilirubin
allowed is 3 mg/dL).
9. In female with childbearing potential, a pregnancy test have to be negative within 72 hours
priors to first dose of study drug. If fertile, patient have to agree to use an effective
method of contraception to avoid pregnancy for the duration of the study.
10. Estimated life expectancy of >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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified