At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed primary transitional cell carcinoma (TCC) with muscularis propria invasion
- ✓Stage T2-4a, N0/N1, M0 disease; or clinical stage T1 grade 3 requiring definitive local therapy
- ✓Undergone transurethral bladder resection within 3–8 weeks prior, with bimanual examination and tumor mapping
- ✓Sufficient tumor tissue available for HER2/neu analysis
- ✕Prior systemic chemotherapy with anthracyclines, taxanes, or any prior chemotherapy for TCC
- ✕Prior pelvic radiotherapy
- ✕History of allergic reaction to study drugs
- ✕History of inflammatory bowel disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Trial of a Combination of Paclitaxel and Trastuzumab With Daily Irradiation or Paclitaxel Alone With Daily Irradiation Following Transurethral Surgery for Non-Cystectomy Candidates With Muscle-Invasive Bladder Cancer
In Brief
A Phase 2 clinical trial evaluating Paclitaxel, Radiation Therapy, and 1 other intervention for Bladder Urothelial Carcinoma and 3 related conditions. Completed, enrolled 70 participants across 184 sites in 2 countries.
Detailed Summary
This phase I/II trial is studying the side effects of giving paclitaxel together with radiation therapy with or without trastuzumab and to see how well it works to kill any remaining tumor cells in patients who have undergone surgery for bladder cancer. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel may also make tumor cells more sensitive to radiation therapy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel together with radiation therapy and trastuzumab may kill more tumor cells. Giving these treatments after surgery may kill any remaining tumor cells.
Study Details
Timeline
Interventions
Given IV
Undergo radiation therapy
Given IV