Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin-unfit Urothelial Carcinoma (COACH)
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin Un-fit Advanced Urothelial Carcinoma: Randomized Phase II Study|
- Response rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Response rate based on RECIST 1.1
- Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Safety according to NCI CTCAE v.4.03
- Progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||October 2010|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Active Comparator: GCb
Gemcitabine plus Carboplatin
Gemcitabine 1000 mg/㎡ D1, D8 plus Carboplatin AUC=4.5 D1 every 3 weeks
Gemcitabine plus Oxaliplatin
Gemcitabine 1000 mg/㎡ D1 plus Oxaliplatin 100 mg/㎡ D1 every 2 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487915
|Korea, Republic of|
|Keimyeong University Dongsan Medical Center|
|Daegu, Korea, Republic of, 700-712|
|Chungnam University Hospital|
|Daejeon, Korea, Republic of, 301-721|
|Korea University Anam Hospital|
|Seoul, Korea, Republic of, 136-705|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Chung Ang University Hospital|
|Seoul, Korea, Republic of, 156-755|