• Conditions: Advanced or metastatic predominantly transitional cell carcinoma of the urothelial tract.; MedDRA version: 15.0Level: LLTClassification code 10046722Term: Urothelial carcinoma bladder stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000272-34-AT
• Lead Sponsor: PIERRE FABRE MEDICAMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-18
• Last Update Posted: 2 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

1) Patients aged = 18 years
2) Histologically confirmed diagnosis of locally advanced or metastatic predominantly transitional cell carcinoma of the urothelium (TCCU) [urinary bladder, kidney, renal pelvis, or ureter]. Not amenable to definitive local/regional therapy.
3) Stable Disease, Partial Response or Complete Response as outcome of 1st line treatment with the gemcitabine-cisplatin combination for advanced/metastatic TCCU (confirmed or not).
4) Completion of 4 cycles of 1st line treatment with the gemcitabine-cisplatin combination for the chemo-naïve advanced/metastatic TCCU patient and no persistence of any adverse event > Grade 1 related to this treatment.
5) Last administration of gemcitabine and cisplatin (i.e. last day of administration of both compounds) = 6 weeks before registration.
6) The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means any assessment or evaluation that would not be part of the routine medical care of the patient.
7) Women of childbearing potential must be using a medically accepted method of contraception (i.e. hormonal contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment.
8) Fertile men must be using an effective method of birth control, if their partners are women of childbearing potential, during the study period and up to 3 months after last administration of study medication.
9) ECOG performance status of 0 or 1 (patients aged = 80 years with ECOG performance status 1 or ECOG performance status 0 and prior irradiation of the pelvic area are not eligible).
10) Estimated life expectancy of at least 3 months
11) Adequate haematological, renal and hepatic functions as evidenced by:
- Absolute Neutrophil Count = 1,500/mm³ (=1.5 x 10^9/L)
- Haemoglobin = 9 g/dL
- Platelet count = 100,000/mm³
- Serum total bilirubin =1.5 x upper limit of normal (ULN)
- Transaminases = 2.5 x ULN [ = 5 times ULN only in case of liver
metastasis]
- Alkaline phosphatase = 5 x ULN
-Calculated creatinine clearance (CrCL) (Cockroft-Gault):
• = 20 mL/min for age < 75 years
• = 40 mL/min for age = 75 to < 80 years
• > 60 mL/min for age = 80 years

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 77
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 77

Exclusion Criteria

1) Patients aged < 18 years
2) Patients with predominantly non-TCCU (adenocarcinoma, squamous cell carcinoma or other).
3) Prior administration of any systemic anti-tumour therapy (other than Gemcitabine-cisplatin-combination) for treatment of TCCU.
4) Progressive Disease during or after 1st line treatment with the gemcitabine cisplatin combination for advanced/metastatic TCCU.
5) Known brain metastasis or leptomeningeal involvement (CT Scan/MRI not required to rule this out unless there is clinical suspicion of CNS disease).
6) Peripheral neuropathy = Grade 2.
7) Any serious, concurrent illness or uncontrolled medical disorder including active infection requiring antibiotics within 2 weeks before registration, uncontrolled cardiac arrhythmia, unstable diabetes mellitus, uncontrolled hypercalcaemia, congestive heart failure, poorly controlled hypertension, unstable angina pectoris, or myocardial infarction within 6 months before registration.
8) Screening-electrocardiogram with any significant modifications suggesting a high risk of occurrence of an acute clinical event (such as angina pectoris, high risk arrhythmia, etc.).
9) Prior other malignancy. Note: Patients who have had another malignancy and who have been disease-free for at least 3 years or patients with a history of successfully treated basal cell carcinoma of the skin or in-situ cervix carcinoma or localised prostate cancer with limited risk of recurrence (pT = 2b, Gleason score = 7) that was incidentally discovered and did not lead to any other treatment apart from prostatectomy are eligible.
10) Known hypersensitivity to vinca alkaloids.
11) Prior radiation to = 30% of the bone marrow or radiation not completed at least 28 days before registration or current persistence of any adverse event >Grade 1 related to this treatment.
12) Major surgery or trauma within 28 days before registration or presence of any major non-healing wound, fracture or ulcer.
13) Prior participation in an interventional clinical study investigating drugs within 30 days before registration, during the treatment period.
14) Current treatment with any potent CYP3A4-inhibitor or -inducer
15) Pregnant or lactating women or women with positive pregnancy test at screening.
16) Any serious and/or unstable pre-existing medical, psychiatric, psychological, familial, sociological, geographical or other condition that could interfere with the patient’s safety, provision of informed consent, or compliance with the study protocol.
17) Prisoners or persons who are compulsory detained (involuntary incarcerated).

Study & Design

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