Treatment of locally advanced or metastatic transitional cell carcinoma with cabazitaxel

ISRCTN	ISRCTN76947550
DOI	https://doi.org/10.1186/ISRCTN76947550
ClinicalTrials.gov (NCT)	NCT01668459
Protocol serial number	RRK4368
Sponsor	University Hospitals Birmingham NHS Foundation Trust (UK)
Funder	Sanofi Aventis (France)

Submission date: 01/11/2012
Registration date: 26/02/2013
Last edited: 07/03/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-trial-cabazitaxel-for-transitional-cell-bladder-cancer-that-has-spread-cab-b1

Contact information

Dr Anjali Zarkar
Scientific

Queen Elizabeth Hospital Birmingham
Cancer Centre
Edgbaston
B15 2TH
United Kingdom

Email	anjali.zarkar@uhb.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised open-label parallel-group study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Cabazitaxel in platinum pre-treated patients with locally advanced or metastatic transitional cell carcinoma who developed disease progression within 12 months of platinum based chemotherapy
Study acronym	Cab B1
Study objectives	The study aims to compare the overall response rate of cabazitaxel treatment versus best supportive care including single agent chemotherapy in patients with locally advanced or metastatic transitional cell carcinoma who developed disease progression within 12 months of platinum based chemotherapy.
Ethics approval(s)	NRES Ethics Committee East Midlands - Leicester, 15/10/2012, ref: 12/EM/0363
Health condition(s) or problem(s) studied	Transitional cell carcinoma
Intervention	Cabazitaxel versus Best Supportive Care Treatment duration: Up to 6 three weekly cycles of chemotherapy (18 weeks)
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Cabazitaxel
Primary outcome measure(s)	Overall response rate. Time Frame: Change from baseline at Week 9 and Week 18
Key secondary outcome measure(s)	1. Overall survival: Defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time will be censored at the earlier of the last date the patient is known to be alive and the study cut-off date. Time Frame: From date of randomisation to the date of tumour progression or death (from any cause) (or survival at study cut-off date), whichever came first up to 12 months after the final patient has completed study treatment. 2. Quality of life, assessed using a validated instrument; the EuroQOL (EQ-5D). Time Frame: Change from baseline at Week 6, Week 12, Week 18, Week 21 3. Safety and tolerability: Dose delays and dose reductions, adverse events, laboratory safety data. Time Frame: From date of randomisation up to 30 days after final dose of study medication
Completion date	31/12/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	96
Key inclusion criteria	1. Written informed consent 2. Age ≥ 18 3. Life expectancy ≥ 12 weeks 4. Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) including mixed pathology with predominantly TCC, with locally advanced (T4b) or metastatic (lymph node or visceral) TCC arising from bladder or upper urinary tracts 5. Treated patients with incidental prostate cancer (pT2, Gleason ≤ 6) and PSA (Prostate Specific Antigen) ≤ 0.5 ng/mL are eligible 6. Measurable disease as per RECIST Criteria 1.1 7. ECOG Performance Status 0-1 8. Previously received first line platinum based treatment 9. Recurrence within 12 months (by RECIST criteria version 1.1) from last cycle of chemotherapy
Key exclusion criteria	1. Previous therapy with a taxane 2. Pure non TCC histologies 3. Grade II or more peripheral neuropathy 4. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrolment in the study 5. Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus) 6. Inadequate organ and bone marrow function as evidenced by: 6.1. Hemoglobin < 9.0 g/dL 6.2. Absolute neutrophil count < 1.5 x 109/L 6.3. Platelet count < 100 x 109/L 6.4. AST/SGOT and/or ALT/SGPT > 2.5 x ULN 6.5. Total bilirubin > 1.0 x ULN 6.6. Serum creatinine > 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance ≤ 30 mL/min should be excluded 7. Symptomatic brain metastases or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement) 8. History of another neoplasm except non-metastatic melanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery, small field radiation or chemotherapy < 5 years prior to randomization 9. History of inflammatory bowel disease, significant bowel obstruction 10. History of hypersensitivity to platinum, gemcitabine, taxanes, Polysorbate-80, or to compounds with similar chemical structures 11. Any of the following events within 6 months prior to randomization: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant arrhythmias (grade 3-4) 12. Concurrent treatment with strong inhibitors of cytochrome P450 3A4 or patients planning to receive these treatments. For patients who were receiving treatment with such agents, a one-week washout period is required prior to randomization 13. Women who are breastfeeding and women of child bearing potential (not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus)) unless in agreement to use an adequate method of contraception during the treatment period and for 6 months after the last dose of the study drug. Men unless in agreement that they will use effective contraception (and condom to protect against exposure to seminal liquid) whilst participating in the trial and for 6 months after the last dose of study medication
Date of first enrolment	01/12/2012
Date of final enrolment	31/12/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Queen Elizabeth Hospital Birmingham

Edgbaston
B15 2TH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/05/2017		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/03/2018: Publication reference added.
12/01/2018: No publications found, verifying study status with principal investigator.