Overview

Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin-unfit Urothelial Carcinoma

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Asan Medical Center
Treatments:
Carboplatin
Cisplatin
Gemcitabine
Oxaliplatin
Criteria
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