Advanced Urothelial Carcinoma
Conditions
Keywords
Cisplatin-unfit condition
Brief summary
Cisplatin-based chemotherapy is the standard regimen for advanced urothelial carcinoma. But cisplatin-unfit patients account for up to 30-40% of patients in clinical practice. Recently reported phase II/III trial of EORTC 30986 comparing gemcitabine/carboplatin (GCb) with MCAVI (Methotrexate, Carboplatin, Vinblastine) suggested that GCb be the preferred regimen over MCAVI based on the response rates, adverse events, and severe acute toxicities. But the grade 3 or worse toxicities associated with GCb are not infrequent and need more effective and more tolerable regimens. GemOx has been reported to be effective and have very favorable toxicity profiles.
Interventions
DRUGGCb
Gemcitabine 1000 mg/㎡ D1, D8 plus Carboplatin AUC=4.5 D1 every 3 weeks
DRUGGemOx
Gemcitabine 1000 mg/㎡ D1 plus Oxaliplatin 100 mg/㎡ D1 every 2 weeks
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cytologically of histologically confirmed urothelial carcinoma * Locally advanced or metastatic disease * Measurable disease according to RECIST v.1.1 * ECOG PS 0-2 * Cisplatin-unfit condition (any of the followings: NYHA functional class 3, creatinine clearance 30-60 ml/min, and ECOG PS=2) * Adequate organ function * Chemotherapy-naive
Exclusion criteria
* Histology other than urothelial carcinoma, but squamous cell carcinoma or adenocarcinoma mixed with urothelial carcinoma are allowed * CNS metastases * Peripheral neuropathy grade 2 or worse * Serious medical or surgical conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 12 weeks | Response rate based on RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 12 months | Safety according to NCI CTCAE v.4.03 |
| Progression-free survival | 1 year | — |
| Overall survival | 1 year | — |
Countries
South Korea
Contacts
Primary ContactJae-Lyun Lee, MD, PhD
Backup ContactJeong-Mi Ko, MSc
Outcome results
None listed