Treatment of locally advanced or metastatic transitional cell carcinoma with cabazitaxel
| ISRCTN | ISRCTN76947550 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76947550 |
| ClinicalTrials.gov number | NCT01668459 |
| Secondary identifying numbers | RRK4368 |
- 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
Contact information
Dr Anjali Zarkar
Scientific
Scientific
Queen Elizabeth Hospital Birmingham
Cancer Centre
Edgbaston
B15 2TH
United Kingdom
| anjali.zarkar@uhb.nhs.uk |
Study information
| Study design | Randomised open-label parallel-group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cabazitaxel |
| Primary outcome measure | Overall response rate. Time Frame: Change from baseline at Week 9 and Week 18 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/12/2012 |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 96 (25 patients will be initially recruited and after intermin analysis, a further 71 patients may be recruited) |
| 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
- England
- United Kingdom
Study participating centre
Queen Elizabeth Hospital Birmingham
Edgbaston
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Sponsor information
University Hospitals Birmingham NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Chris Counsell
Queen Elizabeth Hospital Birmingham
Edgbaston
B15 2TH
England
United Kingdom
| Website | http://www.uhb.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/014ja3n03 |
Funders
Funder type
Industry
Sanofi Aventis (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
07/03/2018: Publication reference added.
12/01/2018: No publications found, verifying study status with principal investigator.
