New chemo cocktail shows promise for invasive bladder cancer
NCT ID NCT01616875
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested a combination of two chemotherapy drugs, cabazitaxel and cisplatin, given before surgery to remove the bladder in 28 patients with invasive bladder cancer. The goal was to see if the drugs could shrink the tumor enough to improve outcomes. The study also looked at how long patients stayed cancer-free after surgery and included optional MRI scans and blood tests to track the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cabazitaxel and cisplatin chemotherapy
- What this could lead to
- If this combination works well, it could point toward a more effective treatment before surgery for invasive bladder cancer, potentially improving outcomes.
- What could go wrong
- This is a small, early-phase trial with only 28 participants, so results may not apply to everyone. The chemotherapy also has side effects like kidney damage and nerve problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
28 people
The number who actually took part.
- Started
-
Jul 2012
- Finished
-
Jan 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years * Histologically confirmed primary transitional cell carcinoma (TCC) of the urinary bladder * T2 to T4 disease, N0 M0 determined by computerised tomography (CT) imaging and biopsy or transurethral resection * Eastern Co-operative Oncology Group (ECOG) Performance status 0 or 1 * Glomerular filtration rate (GFR) ≥60ml/min. * Written, informed consent Exclusion Criteria * ECOG Performance Status ≥ 2 * Lymph node involvement or metastatic disease * Prior surgery (except transurethral resection of bladder tumour), radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrolment * Active Grade ≥2 peripheral neuropathy * Active secondary cancers * History of severe hypersensitivity reaction (≥Grade 3) to polysorbate 80 containing drugs * Other concurrent serious illness or medical conditions * Inadequate organ function as evidenced by peripheral blood counts at enrolment: * Electrocardiogram (ECG) evidence of uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension, history of congestive heart failure, or myocardial infarction within last 6 months. * Uncontrolled diabetes mellitus. * Active uncontrolled gastro-oesophageal reflux disease (GORD). * Active infection requiring systemic antibiotic or anti-fungal medication * Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment. * Concurrent or planned treatment with strong inhibitors of cytochrome P450 3A4/5. A 1-week washout period is necessary for patients who are already on these treatments. * Concurrent or planned treatment with strong inducers of cytochrome P450 3A4/5. A 1-week washout period is necessary for patients who are already on these treatments. * Contraindications to cisplatin. * Patient with reproductive potential not implementing an accepted and effective method of contraception.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Infiltrating bladder urothelial carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Bristol Haematology + Oncology Centre, Horfield Road
Bristol, BS2 8ED, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.