Bladder Cancer Clinical Trial
Official title:
A Sequential Approach to the Treatment of Muscle Invasive, Non-Metastatic Urothelial Carcinoma of the Bladder: A Phase II Trial of Neoadjuvant Gemcitabine, Paclitaxel and Carboplatin With Molecular Correlates
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells and
decrease the need for surgery.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by
observation or surgery to remove the bladder (cystectomy) in treating patients who have
stage II or stage III cancer of the urothelium.
OBJECTIVES:
- Determine the pathologic complete response of patients with stage II or III
transitional cell cancer of the urothelium treated with neoadjuvant gemcitabine,
paclitaxel, and carboplatin followed by observation or immediate cystectomy.
- Determine, preliminarily, if molecular markers predict response, survival, and tumor
recurrence in patients treated with these regimens.
- Determine recurrence rates and cystectomy-free survival of patients who choose
observation after an initial response to neoadjuvant chemotherapy.
- Compare the survival of patients treated with neoadjuvant chemotherapy followed by
cystectomy vs observation.
- Determine the feasibility, tolerability, and toxicity of these regimens in these
patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 30 minutes on days 1
and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 3
courses in the absence of disease progression or unacceptable toxicity.
Within 4-8 weeks after completion of neoadjuvant chemotherapy, patients undergo a third
transurethral resection of bladder tumor.
Patients with T0 disease after neoadjuvant chemotherapy may choose to undergo observation.
These patients undergo cystoscopies with biopsies every 3 months for 1 year, every 4 months
for 1 year, and then every 6 months until disease progression.
Patients with T1 disease or greater after neoadjuvant chemotherapy undergo immediate
cystectomy. Patients with T0 disease may also choose this option. Patients undergoing
immediate cystectomy are followed every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 95 patients will be accrued for this study within 2 years.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06034015 -
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers
|
Phase 1 | |
| Recruiting |
NCT04235764 -
En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
|
||
| Completed |
NCT02371447 -
VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04081246 -
Transurethral Modified En Bloc Resection For Large Bladder Tumours.
|
N/A | |
| Recruiting |
NCT06059547 -
Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for Treatment of Muscle Invasive Bladder Cancer
|
Phase 2 | |
| Terminated |
NCT04779489 -
Checkpoint Inhibitor and Radiation Therapy in Bulky, Node-Positive Bladder Cancer
|
N/A | |
| Not yet recruiting |
NCT04493489 -
Propranolol Adjuvant Treatment of Bladder Cancer
|
Phase 2 | |
| Completed |
NCT03520231 -
Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases
|
Phase 2 | |
| Recruiting |
NCT04537221 -
Nordic Cystectomy Study III - Transfusion
|
||
| Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
| Completed |
NCT01955408 -
Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment
|
N/A | |
| Completed |
NCT04487457 -
Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
|
||
| Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
| Recruiting |
NCT05562791 -
A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer
|
Phase 1 | |
| Completed |
NCT00199849 -
NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
|
Phase 1 | |
| Completed |
NCT02781428 -
To Detect the Sensitivity of the UroMark Assay
|
||
| Recruiting |
NCT04738630 -
Study of HX008 for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
|
Phase 2 | |
| Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 | |
| Active, not recruiting |
NCT03978624 -
Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer
|
Phase 2 | |
| Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A |